| A | B | C | D | E | F | G | H | I | J | K | L | M | N | O | P | Q | R | S | T | U | V | W | X | Y | Z | AA | AB | AC | AD | AE | AF | AG | AH | |
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1 | INFO | Title | Germ Cell Tumors (GCT) Data Dictionary | |||||||||||||||||||||||||||||||
2 | INFO | Name | gct_dev | |||||||||||||||||||||||||||||||
3 | INFO | Release Notes | ||||||||||||||||||||||||||||||||
4 | INFO | Parent Data Model | pcdc_dev | |||||||||||||||||||||||||||||||
5 | INFO | License | Creative Commons Attribution-NonCommercial 4.0 International License (https://creativecommons.org/licenses/by-nc/4.0/) | |||||||||||||||||||||||||||||||
6 | INFO | D4CG Data Modeling Wiki | https://docs.pedscommons.org/ | |||||||||||||||||||||||||||||||
7 | INFO | Disease Consortium Information | https://commons.cri.uchicago.edu/pcdc/ | |||||||||||||||||||||||||||||||
8 | INFO | Description | Germ Cell Tumors (GCT) Data Dictionary | |||||||||||||||||||||||||||||||
9 | INFO | Total Variables | ||||||||||||||||||||||||||||||||
10 | ||||||||||||||||||||||||||||||||||
11 | RowType | VariableName | DataType | Tier | VariableDescription | VariableCode | PermissibleValue | ValueDescription | ValueCode | ImplementationNotes | Mappings | Modeling notes (Will be ignored in processing) | ||||||||||||||||||||||
12 | ||||||||||||||||||||||||||||||||||
13 | DD | Protocol | ||||||||||||||||||||||||||||||||
14 | TD | Subject Characteristics | ||||||||||||||||||||||||||||||||
15 | TG | One row per subject per study | ||||||||||||||||||||||||||||||||
16 | VD | HONEST_BROKER_SUBJECT_ID | String | 1 - contributors must include, regardless of the resource cost | The identifier assigned to the subject by the honest broker. An individual, organization or system acting for, or on behalf of, a covered entity to collect and provide health information to research investigators in such a manner whereby it would not be reasonably possible for the investigators or others to identify the corresponding patients-subjects directly or indirectly. The honest broker cannot be one of the investigators. The information provided to the investigators by the honest broker may incorporate linkage codes to permit information collation and/or subsequent inquiries (i.e., a "re-identification code"), however the information linking this re- identification code to the patient's identity must be retained by the honest broker and subsequent inquiries are conducted through the honest broker. | ncit:C168949 | _undefined_ | _undefined_ | _undefined_ | |||||||||||||||||||||||||
17 | VD | CONSORTIUM | Enum | 1 - contributors must include, regardless of the resource cost | The consortium under which this data is being contributed to the Pediatric Cancer Data Commons. | ncit:C61538 | _undefined_ | _undefined_ | _undefined_ | New VD | ||||||||||||||||||||||||
18 | PD | MaGIC | Malignant Germ Cell International Consortium (MaGIC) | ncit:C192759 | New PD | |||||||||||||||||||||||||||||
19 | VD | DATA_CONTRIBUTOR_ID | Enum | 1 - contributors must include, regardless of the resource cost | An identifier assigned to a data contributor. | ncit:C168950 | _undefined_ | _undefined_ | _undefined_ | |||||||||||||||||||||||||
20 | PD | AIEOP | Italian Association of Pediatric Hematology and Oncology. A group from Bologna, Italy, comprised mainly of pediatricians, hematologists, oncologists, surgeons, biologists, nurses and psychologists who are devoted to addressing the problems of hematology, oncology and immunology in the child and adolescent. | ncit:C168887 | ||||||||||||||||||||||||||||||
21 | PD | COG | Children's Oncology Group. An NCI-supported clinical cooperative group formed by the merger of the four national pediatric cancer research organizations: the Children's Cancer Group, the Intergroup Rhabdomyosarcoma Study Group, the National Wilms Tumor Study Group, and the Pediatric Oncology Group. The primary objective of the organization is to conduct clinical trials of new therapies for childhood and adolescent cancer. COG develops and coordinates clinical trials conducted at the 238 member institutions that include cancer centers of all major universities and teaching hospitals throughout the U.S. and Canada, as well as sites in Europe and Australia. COG members include over 5000 cancer researchers. | ncit:C39353 | ||||||||||||||||||||||||||||||
22 | PD | MRC | Medical Research Council. A publicly funded organization that is part of United Kingdom Research and Innovation, and is dedicated to improving human health through world-class medical research. | ncit:C168892 | ||||||||||||||||||||||||||||||
23 | PD | CCLG | Children's Cancer and Leukaemia Group. A children's cancer charity and United Kingdom and Ireland's professional association for those involved in the treatment and care of children with cancer. | ncit:C177327 | ||||||||||||||||||||||||||||||
24 | PD | NRG-Oncology | NRG-Oncology. A leading protocol organization within the National Clinical Trials Network that seeks to improve the lives of cancer patients by conducting practice-changing, multi-institutional clinical and translational research. | ncit:C177331 | ||||||||||||||||||||||||||||||
25 | PD | SFCE | Societe Francaise de Lutte contre les Cancers et Leucemies de l'Enfant et de l'Adolescent. An association founded in France in 2003 which promotes the organization of care and scientific research in the field of childhood and adolescent cancer. | ncit:C177328 | ||||||||||||||||||||||||||||||
26 | PD | SOPOBE | Brazilian Society of Pediatric Oncology. A society founded in 1981 committed to improve the prognosis of children and adolescents with cancer. | ncit:C177329 | ||||||||||||||||||||||||||||||
27 | PD | DFCI | Dana Farber Cancer Institute. An institute founded in 1947 in Boston, Massachusetts, committed to providing treatment for adults and children with cancer, and developing cures with cutting-edge research. | ncit:C177330 | ||||||||||||||||||||||||||||||
28 | VD | STUDY_ID | Enum | 1 - contributors must include, regardless of the resource cost | A sequence of characters used to identify, name, or characterize the study. | ncit:C83082 | _undefined_ | _undefined_ | _undefined_ | |||||||||||||||||||||||||
29 | PD | TGM85 | Paediatric dysgerminoma: Results of three consecutive French germ cell tumours clinical studies (TGM-85/90/95) with late effects study. French patients (≤18years) treated for dysgerminoma between 1985 and 2005 in TGM-85, 90, 95 protocols were included. Since 1985, the French Society of Pediatric Oncology (SFOP) progressively replaced radiotherapy by adjuvant chemotherapy to limit long-term sequela. Treatment was based on primary unilateral oophorectomy followed by prophylactic lymph node irradiation (1985-1998) or a wait-and-see strategy (1998-2005) for localised completely resected tumours (pS1) or by platinum-based chemotherapy for advanced diseases.(Duhil de Bénazé G, Pacquement H, Faure-Conter C, et al. Paediatric dysgerminoma: Results of three consecutive French germ cell tumours clinical studies (TGM-85/90/95) with late effects study. Eur J Cancer. 2018;91:30-37. doi:10.1016/j.ejca.2017.11.030) | ncit:C177332 | ||||||||||||||||||||||||||||||
30 | PD | TGM90 | Paediatric dysgerminoma: Results of three consecutive French germ cell tumours clinical studies (TGM-85/90/95) with late effects study. French patients (≤18years) treated for dysgerminoma between 1985 and 2005 in TGM-85, 90, 95 protocols were included. Since 1985, the French Society of Pediatric Oncology (SFOP) progressively replaced radiotherapy by adjuvant chemotherapy to limit long-term sequelae. Treatment was based on primary unilateral oophorectomy followed by prophylactic lymph node irradiation (1985-1998) or a wait-and-see strategy (1998-2005) for localised completely resected tumours (pS1) or by platinum-based chemotherapy for advanced diseases.(Duhil de Bénazé G, Pacquement H, Faure-Conter C, et al. Paediatric dysgerminoma: Results of three consecutive French germ cell tumours clinical studies (TGM-85/90/95) with late effects study. Eur J Cancer. 2018;91:30-37. doi:10.1016/j.ejca.2017.11.030) | ncit:C177333 | ||||||||||||||||||||||||||||||
31 | PD | TGM95 | Paediatric dysgerminoma: Results of three consecutive French germ cell tumours clinical studies (TGM-85/90/95) with late effects study. French patients (≤18years) treated for dysgerminoma between 1985 and 2005 in TGM-85, 90, 95 protocols were included. Since 1985, the French Society of Pediatric Oncology (SFOP) progressively replaced radiotherapy by adjuvant chemotherapy to limit long-term sequelae. Treatment was based on primary unilateral oophorectomy followed by prophylactic lymph node irradiation (1985-1998) or a wait-and-see strategy (1998-2005) for localised completely resected tumours (pS1) or by platinum-based chemotherapy for advanced diseases.(Duhil de Bénazé G, Pacquement H, Faure-Conter C, et al. Paediatric dysgerminoma: Results of three consecutive French germ cell tumours clinical studies (TGM-85/90/95) with late effects study. Eur J Cancer. 2018;91:30-37. doi:10.1016/j.ejca.2017.11.030) | ncit:C177334 | ||||||||||||||||||||||||||||||
32 | PD | GC1 | Revised Risk Classification for Pediatric Extracranial Germ Cell Tumors Based on 25 Years of Clinical Trial Data From the United Kingdom and United States. Data from seven GCT trials conducted by the Children's Oncology Group (United States) or the Children's Cancer and Leukemia Group (United Kingdom) between 1985 and 2009 were merged to create a data set of patients with stage II to IV disease treated with platinum-based therapy. GC1 is one of the United Kingdom trials where all patients with malignant germ cell tumor with a total of 14 patients. (Frazier AL, Hale JP, Rodriguez-Galindo C, et al. Revised risk classification for pediatric extracranial germ cell tumors based on 25 years of clinical trial data from the United Kingdom and United States. J Clin Oncol. 2015;33(2):195-201. doi:10.1200/JCO.2014.58.3369) | ncit:C113593 | ||||||||||||||||||||||||||||||
33 | PD | GC2 | Revised Risk Classification for Pediatric Extracranial Germ Cell Tumors Based on 25 Years of Clinical Trial Data From the United Kingdom and United States. Data from seven GCT trials conducted by the Children's Oncology Group (United States) or the Children's Cancer and Leukemia Group (United Kingdom) between 1985 and 2009 were merged to create a data set of patients with stage II to IV disease treated with platinum-based therapy. GC2 is one of the United Kingdom trials where all patients with malignant germ cell tumor with a total of 135 patients. (Frazier AL, Hale JP, Rodriguez-Galindo C, et al. Revised risk classification for pediatric extracranial germ cell tumors based on 25 years of clinical trial data from the United Kingdom and United States. J Clin Oncol. 2015;33(2):195-201. doi:10.1200/JCO.2014.58.3369) | ncit:C177336 | ||||||||||||||||||||||||||||||
34 | PD | GOG0078 | Revised Risk Classification for Pediatric Extracranial Germ Cell Tumors Based on 25 Years of Clinical Trial Data From the United Kingdom and United States. Data from seven GCT trials conducted by the Children's Oncology Group (United States) or the Children's Cancer and Leukemia Group (United Kingdom) between 1985 and 2009 were merged to create a data set of patients with stage II to IV disease treated with platinum-based therapy. GC1 is one of the United Kingdom trials where all patients with malignant germ cell tumor with a total of 14 patients. (Frazier AL, Hale JP, Rodriguez-Galindo C, et al. Revised risk classification for pediatric extracranial germ cell tumors based on 25 years of clinical trial data from the United Kingdom and United States. J Clin Oncol. 2015;33(2):195-201. doi:10.1200/JCO.2014.58.3369) | ncit:C177337 | ||||||||||||||||||||||||||||||
35 | PD | GOG0090 | Revised Risk Classification for Pediatric Extracranial Germ Cell Tumors Based on 25 Years of Clinical Trial Data From the United Kingdom and United States. Data from seven GCT trials conducted by the Children's Oncology Group (United States) or the Children's Cancer and Leukemia Group (United Kingdom) between 1985 and 2009 were merged to create a data set of patients with stage II to IV disease treated with platinum-based therapy. GC1 is one of the United Kingdom trials where all patients with malignant germ cell tumor with a total of 14 patients. (Frazier AL, Hale JP, Rodriguez-Galindo C, et al. Revised risk classification for pediatric extracranial germ cell tumors based on 25 years of clinical trial data from the United Kingdom and United States. J Clin Oncol. 2015;33(2):195-201. doi:10.1200/JCO.2014.58.3369) | ncit:C177338 | ||||||||||||||||||||||||||||||
36 | PD | GOG0116 | Revised Risk Classification for Pediatric Extracranial Germ Cell Tumors Based on 25 Years of Clinical Trial Data From the United Kingdom and United States. Data from seven GCT trials conducted by the Children's Oncology Group (United States) or the Children's Cancer and Leukemia Group (United Kingdom) between 1985 and 2009 were merged to create a data set of patients with stage II to IV disease treated with platinum-based therapy. GC1 is one of the United Kingdom trials where all patients with malignant germ cell tumor with a total of 14 patients. (Frazier AL, Hale JP, Rodriguez-Galindo C, et al. Revised risk classification for pediatric extracranial germ cell tumors based on 25 years of clinical trial data from the United Kingdom and United States. J Clin Oncol. 2015;33(2):195-201. doi:10.1200/JCO.2014.58.3369) | ncit:C177339 | ||||||||||||||||||||||||||||||
37 | PD | P9749 | Revised Risk Classification for Pediatric Extracranial Germ Cell Tumors Based on 25 Years of Clinical Trial Data From the United Kingdom and United States. Data from seven GCT trials conducted by the Children's Oncology Group (United States) or the Children's Cancer and Leukemia Group (United Kingdom) between 1985 and 2009 were merged to create a data set of patients with stage II to IV disease treated with platinum-based therapy. GC1 is one of the United Kingdom trials where all patients with malignant germ cell tumor with a total of 14 patients. (Frazier AL, Hale JP, Rodriguez-Galindo C, et al. Revised risk classification for pediatric extracranial germ cell tumors based on 25 years of clinical trial data from the United Kingdom and United States. J Clin Oncol. 2015;33(2):195-201. doi:10.1200/JCO.2014.58.3369) | ncit:C177340 | ||||||||||||||||||||||||||||||
38 | PD | POG9049 | Revised Risk Classification for Pediatric Extracranial Germ Cell Tumors Based on 25 Years of Clinical Trial Data From the United Kingdom and United States. Data from seven GCT trials conducted by the Children's Oncology Group (United States) or the Children's Cancer and Leukemia Group (United Kingdom) between 1985 and 2009 were merged to create a data set of patients with stage II to IV disease treated with platinum-based therapy. GC1 is one of the United Kingdom trials where all patients with malignant germ cell tumor with a total of 14 patients. (Frazier AL, Hale JP, Rodriguez-Galindo C, et al. Revised risk classification for pediatric extracranial germ cell tumors based on 25 years of clinical trial data from the United Kingdom and United States. J Clin Oncol. 2015;33(2):195-201. doi:10.1200/JCO.2014.58.3369) | ncit:C177341 | ||||||||||||||||||||||||||||||
39 | PD | AGCT01P1 | Revised Risk Classification for Pediatric Extracranial Germ Cell Tumors Based on 25 Years of Clinical Trial Data From the United Kingdom and United States. Data from seven GCT trials conducted by the Children's Oncology Group (United States) or the Children's Cancer and Leukemia Group (United Kingdom) between 1985 and 2009 were merged to create a data set of patients with stage II to IV disease treated with platinum-based therapy. GC1 is one of the United Kingdom trials where all patients with malignant germ cell tumor with a total of 14 patients. (Frazier AL, Hale JP, Rodriguez-Galindo C, et al. Revised risk classification for pediatric extracranial germ cell tumors based on 25 years of clinical trial data from the United Kingdom and United States. J Clin Oncol. 2015;33(2):195-201. doi:10.1200/JCO.2014.58.3369) | ncit:C177342 | ||||||||||||||||||||||||||||||
40 | PD | AGCT0132 | Revised Risk Classification for Pediatric Extracranial Germ Cell Tumors Based on 25 Years of Clinical Trial Data From the United Kingdom and United States. Data from seven GCT trials conducted by the Children's Oncology Group (United States) or the Children's Cancer and Leukemia Group (United Kingdom) between 1985 and 2009 were merged to create a data set of patients with stage II to IV disease treated with platinum-based therapy. GC1 is one of the United Kingdom trials where all patients with malignant germ cell tumor with a total of 14 patients. (Frazier AL, Hale JP, Rodriguez-Galindo C, et al. Revised risk classification for pediatric extracranial germ cell tumors based on 25 years of clinical trial data from the United Kingdom and United States. J Clin Oncol. 2015;33(2):195-201. doi:10.1200/JCO.2014.58.3369) | ncit:C177343 | ||||||||||||||||||||||||||||||
41 | PD | AGCT0521 | Treatment of Refractory Germ Cell Tumors in Children with Paclitaxel, Ifosfamide and Carboplatin: A Report from The Children’s Oncology Group AGCT0521 Study. TIP (paclitaxel, ifosfamide, cisplatin) is commonly used as salvage for malignant germ cell tumors (MGCT) in adults; however, additional administration of cisplatin at a young age could cause significant short and long-term toxicities in a group of patients with high expected salvage. Because carboplatin has been shown to be effective in pediatric MGCT with less toxicity, the TIP regimen was modified by substituting carboplatin for cisplatin. This study reports the results using paclitaxel, ifosfamide and carboplatin (TIC). (Pashankar F, Frazier AL, Krailo M, et al. Treatment of refractory germ cell tumors in children with paclitaxel, ifosfamide, and carboplatin: A report from the Children's Oncology Group AGCT0521 study. Pediatr Blood Cancer. 2018;65(8):e27111. doi:10.1002/pbc.27111) | ncit:C177344 | ||||||||||||||||||||||||||||||
42 | PD | TE04 | A prospective study of surveillance in stage 1 non-seminomatous testicular tumours. This was a prospective, randomized study, looking at men who were diagnosed with a type of testis cancer called stage I nonseminomatous germ cell testicular tumour (NSGCT) and who then had an operation to remove one or both testicles (orchidectomy). (The Medical Research Council, https://www.mrcctu.ucl.ac.uk/studies/all-studies/t/te04/) | ncit:C20299 | ||||||||||||||||||||||||||||||
43 | PD | TE05 | Adjuvant bleomycin, etoposide and cisplatin (BEP) in the treatment of "high risk" stage I non-seminomatous germ cell tumours. The aim of the TE05 randomized study was to see whether a short course (approximately 6 weeks) of chemotherapy could help reduce the risk of NSGCT recurring. (The Medical Research Council, https://www.mrcctu.ucl.ac.uk/studies/all-studies/t/te05/) | ncit:C177346 | ||||||||||||||||||||||||||||||
44 | PD | TE08 | A randomised trial of two vs five CT scans in the surveillance of patients with stage I non-seminomatous germ cell tumours of the testis. This randomized trial aimed to find out how often CT scans should be done in these men, as doctors and researchers weren’t sure about this. This study found that it is acceptable to give CT scans to men 3 and 12 months after surgery if there is a low risk of the cancer coming back. (The Medical Research Council, https://www.mrcctu.ucl.ac.uk/studies/all-studies/t/te08/) | ncit:C177347 | ||||||||||||||||||||||||||||||
45 | PD | TE22 | Fluorodeoxyglucose Positron Emission Tomography in the Prediction of Relapse in Patients With High-Risk, Clinical Stage I Nonseminomatous Germ Cell Tumors: Preliminary Report of MRC Trial TE22—The NCRI Testis Tumour Clinical Study Group. This study examined whether an 18fluorodeoxyglucose positron emission tomography (18FDG PET) scan could identify patients without occult metastatic disease for whom surveillance is an attractive option. (DOI: 10.1200/JCO.2006.09.3831 Journal of Clinical Oncology 25, no. 21 (July 20, 2007) 3090-3095.) | ncit:C177348 | ||||||||||||||||||||||||||||||
46 | PD | TE09 | Randomised trial of carboplatin- vs cisplatin based chemotherapy for good prognosis metastatic non-seminomatous germ cell tumours. The TE09 trial aimed to find out if another chemotherapy drug, called carboplatin, could work as well as cisplatin. (The Medical Research Council and the European Organisation for Research and Treatment of Cancer (EORTC), https://www.mrcctu.ucl.ac.uk/studies/all-studies/t/te09/) | ncit:C177349 | ||||||||||||||||||||||||||||||
47 | PD | TE13 | A randomised trial of BEP (bleomycin, etoposide, cisplatin) vs BOP/VIP-B (bleomycin, vincristine, cisplatin, etoposide, ifosfamide cisplatin, bleomycin) and of the same regimens with or without G-CSF in poor prognosis metastatic germ cell tumours. The TE13 trial aimed to compare BEP with BOP/VIP-B. It also looked at the use of a drug called filograstim, or G-CSF, to see if it could reduce some of the side effects associated with the drugs. (The Medical Research Council and the European Organisation for Research and Treatment of Cancer (EORTC), https://www.mrcctu.ucl.ac.uk/studies/all-studies/t/te13/) | ncit:C177350 | ||||||||||||||||||||||||||||||
48 | PD | TE20 | A randomised trial of 3 cycles of BEP versus 3 cycles of BEP plus 1 cycle of EP and the 3-day versus the 5-day schedule in good prognosis metastatic germ cell cancer. This trial aimed to find out whether men could be given 3 cycles of chemotherapy drugs instead of 4, and how each cycle of chemotherapy should be given – over 3 days or over 5 days. (The UK Medical Research Council and the European Organisation for Research and Treatment of Cancer (EORTC), https://www.mrcctu.ucl.ac.uk/studies/all-studies/t/te20/) | ncit:C177351 | ||||||||||||||||||||||||||||||
49 | PD | TIP | A phase II trial of TIP (paclitaxel, ifosfamide and cisplatin) given as second-line (post-BEP) salvage chemotherapy for patients with metastatic germ cell cancer: a medical research council trial. This phase II trial describes the use of TIP chemotherapy (paclitaxel, ifosfamide and cisplatin) as salvage for patients with metastatic germ cell cancer (GCC) who have failed initial BEP (bleomycin, etoposide and cisplatin) chemotherapy. (Mead GM, Cullen MH, Huddart R, et al. A phase II trial of TIP (paclitaxel, ifosfamide and cisplatin) given as second-line (post-BEP) salvage chemotherapy for patients with metastatic germ cell cancer: a medical research council trial. Br J Cancer. 2005;93(2):178-184. doi:10.1038/sj.bjc.6602682) | ncit:C90069 | ||||||||||||||||||||||||||||||
50 | PD | DFCI Registry | An institutional registry of adult germ cell tumor patients from the Dana Farber Cancer Institute (DFCI) | New PD | ||||||||||||||||||||||||||||||
51 | PD | TCGM2004 | Mediastinal Germ Cell Tumors in Pediatric Patients: A Report From the Italian Association of Pediatric Hematology and Oncology. Primary mediastinal germ cell tumors (GCTs) are rare in children and still represent a challenge for both adult and pediatric oncologists because of their worse outcome compared to their gonadal counterpart. Prospectively collected data concerning patients enrolled in the Italian Association of Pediatric Haematology and Oncology study on malignant GCTs (AIEOP TCGM2004) protocol for the treatment of GCTs were analyzed. Patients with malignant mediastinal primary GCTs were included in this study. (De Pasquale, M., Crocoli, A., Conte, M., Indolfi, P., Mediastinal Germ Cell Tumors in Pediatric Patients: A Report From the Italian Association of Pediatric Hematology and Oncology, Pediatr Blood Cancer 2016;63:808–812) | ncit:C187201 | ||||||||||||||||||||||||||||||
52 | VD | AGE_AT_ENROLLMENT | Integer | 2 - contributors should prioritize inclusion if resources are available | The age (in days) when the subject enrolled in the study. | ncit:C168843 | _undefined_ | _undefined_ | _undefined_ | ConditionalStatement: if 'ENROLLED_STATUS' == 'Enrolled' | ConditionalStatement: Mandatory if "AGE_AT_DIAG_ASSESSMENT" is null | ||||||||||||||||||||||||
53 | VD | YEAR_AT_ENROLLMENT | Integer | 2 - contributors should prioritize inclusion if resources are available | The year at which a subject enrolled in a study. | ncit:C177353 | _undefined_ | _undefined_ | _undefined_ | ConditionalStatement: if 'ENROLLED_STATUS' == 'Enrolled' | ||||||||||||||||||||||||
54 | VD | TREATMENT_ARM | Enum | 2 - contributors should prioritize inclusion if resources are available | A specific treatment plan within a clinical trial that describes the activities a subject will be involved in as he or she progresses through the study. | ncit:C15538 | _undefined_ | _undefined_ | _undefined_ | |||||||||||||||||||||||||
55 | PD | TE09:BEP (Cisplatin) | Patients randomized with the following course sequence: 1) Bleomycin, etoposide and cisplatin (BEP) | New PD | ||||||||||||||||||||||||||||||
56 | PD | TE09:CEP (Carboplatin) | Patients randomized with the following course sequence: 1): Carboplatin and etoposide (Carboplatin is only used if patients cannot tolerate cisplatin) | New PD | ||||||||||||||||||||||||||||||
57 | PD | TE13:BEP | Patients randomized with the following course sequence: 1) Bleomycin, etoposide and cisplatin (BEP) | New PD | ||||||||||||||||||||||||||||||
58 | PD | TE13:BEP + GCSF | Patients randomized with the following course sequence: 1) Bleomycin, etoposide and cisplatin (BEP), 2) Filograstim (GCSF) | New PD | ||||||||||||||||||||||||||||||
59 | PD | TE13:BOP/VIP | Patients randomized with the following course sequence: 1) Bleomycin, vincristine, cisplatin (BOP), 2) Etoposide, ifosfamide, cisplatin and bleomycin (VIP-B) | New PD | ||||||||||||||||||||||||||||||
60 | PD | TE13:BOP/VIP + GCSF | Patients randomized with the following course sequence: 1) Bleomycin, vincristine, cisplatin (BOP), 2) Etoposide, ifosfamide, cisplatin and bleomycin (VIP-B), 3) Filograstim (GCSF) | New PD | ||||||||||||||||||||||||||||||
61 | PD | TE20:BEP 3 Cycle/3 Day | Patients randomized with the following course sequence: 1) Bleomycin, etoposide and cisplatin (BEP) given 3 cycles over 3 days | New PD | ||||||||||||||||||||||||||||||
62 | PD | TE20:BEP 3 Cycle/5 Day | Patients randomized with the following course sequence: 1) Bleomycin, etoposide and cisplatin (BEP) given 3 cycles over 5 days | New PD | ||||||||||||||||||||||||||||||
63 | PD | TE20:BEP 3 Cycle/Selected 3 Day | Patients randomized with the following course sequence: 1) Bleomycin, etoposide and cisplatin (BEP) given 3 cycles over 3 selected days | New PD | ||||||||||||||||||||||||||||||
64 | PD | TE20:BEP 4 Cycle/3 Day | Patients randomized with the following course sequence: 1) Bleomycin, etoposide and cisplatin (BEP) given 4 cycles over 3 days | New PD | ||||||||||||||||||||||||||||||
65 | PD | TE20:BEP 4 Cycle/5 Day | Patients randomized with the following course sequence: 1) Bleomycin, etoposide and cisplatin (BEP) given 4 cycles over 5 days | New PD | ||||||||||||||||||||||||||||||
66 | PD | TE20:BEP 4 Cycle/Selected 3 Day | Patients randomized with the following course sequence: 1) Bleomycin, etoposide and cisplatin (BEP) given 4 cycles over 3 selected days | New PD | ||||||||||||||||||||||||||||||
67 | VD | EFS_CENSOR_STATUS | Enum | 2 - contributors should prioritize inclusion if resources are available | The status of individuals in a study when their outcome (event occurrence or time to event) is censored or not censored at the time of analysis or data collection. Censoring occurs when an individual has not experienced the event of interest by the end of the study period or at the time of data analysis, often because they were lost to follow-up, withdrew from the study, or the study ended before the event could occur. In event-free survival analysis, these censored individuals are included in the analysis up to the point of censoring and are essential for estimating survival probabilities and analyzing the time to events. | _undefined_ | _undefined_ | _undefined_ | skos:exactMatch [NBL].[v3.0].[Subject Characteristics].[CENSOR_STATUS] | How to generalize and capture time to event -- Brian | ||||||||||||||||||||||||
68 | PD | Censored | The status of a participant or subject in a study whose event or outcome of interest has not yet occurred or has not been observed within the study's follow-up period. Censoring occurs when the event of interest has not happened to a participant by the end of the study or when they are lost to follow-up before the event occurs. | ncit:C118962 | skos:exactMatch [NBL].[v3.0].[Subject Characteristics].[CENSOR_STATUS].[Subject is censored (i.e. has had no events(s))] | |||||||||||||||||||||||||||||
69 | PD | Not Censored | The patient has experienced the event of interest within the study period and has reached the endpoint being evaluated, such as disease progression, relapse, recurrence, or death, and their time to event can be accurately recorded and analyzed. | skos:exactMatch [NBL].[v3.0].[Subject Characteristics].[CENSOR_STATUS].[Subject has had one or more events] | ||||||||||||||||||||||||||||||
70 | PD | Unknown | Reported as unknown by the data contributor. | ncit:C17998 | skos:exactMatch [NBL].[v3.0].[Subject Characteristics].[CENSOR_STATUS].[Unknown] | |||||||||||||||||||||||||||||
71 | PD | Not Reported | Not provided or available. | ncit:C43234 | skos:exactMatch [NBL].[v3.0].[Subject Characteristics].[CENSOR_STATUS].[Not Reported] | |||||||||||||||||||||||||||||
72 | VD | AGE_AT_CENSOR_STATUS | Integer | 2 - contributors should prioritize inclusion if resources are available | The age (in days) of the subject at the time of the event censor status. | _undefined_ | _undefined_ | _undefined_ | ConditionalStatement: if 'EFS_CENSOR_STATUS' not null | |||||||||||||||||||||||||
73 | ||||||||||||||||||||||||||||||||||
74 | ||||||||||||||||||||||||||||||||||
75 | DD | Protocol | ||||||||||||||||||||||||||||||||
76 | TD | Time Period | ||||||||||||||||||||||||||||||||
77 | TG | One row per subject per time period type | ||||||||||||||||||||||||||||||||
78 | VD | HONEST_BROKER_SUBJECT_ID | String | 1 - contributors must include, regardless of the resource cost | The identifier assigned to the subject by the honest broker. An individual, organization or system acting for, or on behalf of, a covered entity to collect and provide health information to research investigators in such a manner whereby it would not be reasonably possible for the investigators or others to identify the corresponding patients-subjects directly or indirectly. The honest broker cannot be one of the investigators. The information provided to the investigators by the honest broker may incorporate linkage codes to permit information collation and/or subsequent inquiries (i.e., a "re-identification code"), however the information linking this re- identification code to the patient's identity must be retained by the honest broker and subsequent inquiries are conducted through the honest broker. | ncit:C168949 | _undefined_ | _undefined_ | _undefined_ | |||||||||||||||||||||||||
79 | VD | SUBMITTER_ID | String | 2 - contributors should prioritize inclusion if resources are available | An ID provided by the data contributor that identifies a unique time period and that is referenced throughout subsequent tabels in the TIME_PERIOD_SUBMITTER_ID variables. | _undefined_ | _undefined_ | _undefined_ | New VD | |||||||||||||||||||||||||
80 | VD | PARENT_SUBMITTER_ID | String | 2 - contributors should prioritize inclusion if resources are available | The SUBMITTER_ID of the time period in whose context a subsequent time period takes place. For example, multiple treatment courses occuring the "Initial Diagnosis" period would each reference the SUBMITTER_ID of the "Initial Diagnosis" period as their PARENT_SUBMITTER_ID. | _undefined_ | _undefined_ | _undefined_ | New VD | |||||||||||||||||||||||||
81 | VD | TIME_PERIOD_TYPE | Enum | 2 - contributors should prioritize inclusion if resources are available | The type of time period being reported. | _undefined_ | _undefined_ | _undefined_ | New VD | |||||||||||||||||||||||||
82 | PD | Disease Phase | The stage or period of an individual's disease. | ncit:C168878 | New PD | |||||||||||||||||||||||||||||
83 | VD | DISEASE_PHASE | Enum | 2 - contributors should prioritize inclusion if resources are available | The phase of the cancer treatment process during which relevant observations were recorded. This variable is used across domains to frame the timing of these longitudinal observations and reduce the number of redundant variables needed to report similar concepts (see "Disease Phase Timing and Course Table" in the documentation for additional guidance). | ncit:C168878 | _undefined_ | _undefined_ | _undefined_ | Disease Phase could be "Initial Diagnosis" phase, or a "Relapse" phase, etc... | skos:exactMatch [GCT].[v1.0].[Disease Phase Timing].[DISEASE_PHASE] | |||||||||||||||||||||||
84 | PD | Initial Diagnosis | The first diagnosis of the individual's condition. | ncit:C156813 | skos:exactMatch [GCT].[v1.0].[Disease Phase Timing].[DISEASE_PHASE].[Initial Diagnosis] | |||||||||||||||||||||||||||||
85 | PD | Relapse | The return of a disease after a period of remission. | ncit:C38155 | skos:exactMatch [GCT].[v1.0].[Disease Phase Timing].[DISEASE_PHASE].[Relapse] | |||||||||||||||||||||||||||||
86 | VD | TIME_PERIOD_NUMBER | Integer | 2 - contributors should prioritize inclusion if resources are available | This variable indicates the ordinal numbering of time periods of the same TIME_PERIOD_TYPE within its various subgroups (e.g., Relapse 1, Relapse 2, Relapse 3, etc.). The observations across domains can therefore be organized longitudinally without the need for specific dates. | _undefined_ | _undefined_ | _undefined_ | skos:broadMatch [GCT].[v1.0].[Disease Phase Timing].[DISEASE_PHASE_NUMBER] | |||||||||||||||||||||||||
87 | VD | YEAR_AT_START | Integer | 2 - contributors should prioritize inclusion if resources are available | The year at the start of the indicated time period. | _undefined_ | _undefined_ | _undefined_ | skos:exactMatch [GCT].[v1.0].[Disease Phase Timing].[YEAR_AT_DISEASE_PHASE] | |||||||||||||||||||||||||
88 | VD | AGE_AT_START | Integer | 2 - contributors should prioritize inclusion if resources are available | The age (in days) of the patient at the start of the reported time period. | _undefined_ | _undefined_ | _undefined_ | skos:broadMatch [GCT].[v1.0].[Disease Phase Timing].[AGE_AT_DISEASE_PHASE] | |||||||||||||||||||||||||
89 | ||||||||||||||||||||||||||||||||||
90 | ||||||||||||||||||||||||||||||||||
91 | DD | Demographics | ||||||||||||||||||||||||||||||||
92 | TD | Demographics | ||||||||||||||||||||||||||||||||
93 | TG | One row per subject | ||||||||||||||||||||||||||||||||
94 | VD | HONEST_BROKER_SUBJECT_ID | String | 1 - contributors must include, regardless of the resource cost | The identifier assigned to the subject by the honest broker. An individual, organization or system acting for, or on behalf of, a covered entity to collect and provide health information to research investigators in such a manner whereby it would not be reasonably possible for the investigators or others to identify the corresponding patients-subjects directly or indirectly. The honest broker cannot be one of the investigators. The information provided to the investigators by the honest broker may incorporate linkage codes to permit information collation and/or subsequent inquiries (i.e., a "re-identification code"), however the information linking this re- identification code to the patient's identity must be retained by the honest broker and subsequent inquiries are conducted through the honest broker. | ncit:C168949 | _undefined_ | _undefined_ | _undefined_ | |||||||||||||||||||||||||
95 | VD | SEX | Enum | 1 - contributors must include, regardless of the resource cost | The biological sex of the subject. | ncit:C28421 | _undefined_ | _undefined_ | _undefined_ | |||||||||||||||||||||||||
96 | PD | Male | A person who belongs to the sex that normally produces sperm. The term is used to indicate biological sex distinctions, cultural gender role distinctions, or both. | ncit:C20197 | ||||||||||||||||||||||||||||||
97 | PD | Female | A person who belongs to the sex that normally produces ova. The term is used to indicate biological sex distinctions, or cultural gender role distinctions, or both. | ncit:C16576 | ||||||||||||||||||||||||||||||
98 | PD | Undifferentiated | Sex could not be determined; not uniquely defined; undifferentiated. | ncit:C41438 | ||||||||||||||||||||||||||||||
99 | PD | Unknown | Reported as unknown by the data contributor. | ncit:C17998 | ||||||||||||||||||||||||||||||
100 | PD | Not Reported | Not provided or available. | ncit:C43234 |