Ignite Creation Date:
2025-12-25 @ 2:37 AM
Ignite Modification Date:
2026-02-20 @ 10:59 PM
Study NCT ID:
NCT02099734
Status:
RECRUITING
Last Update Posted:
2025-07-09
First Post:
2014-03-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Germ Cell Tumor and Testicular Tumor DNA Registry
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009373', 'term': 'Neoplasms, Germ Cell and Embryonal'}, {'id': 'D013736', 'term': 'Testicular Neoplasms'}], 'ancestors': [{'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D005834', 'term': 'Genital Neoplasms, Male'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D005832', 'term': 'Genital Diseases, Male'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D013733', 'term': 'Testicular Diseases'}, {'id': 'D006058', 'term': 'Gonadal Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D011795', 'term': 'Surveys and Questionnaires'}], 'ancestors': [{'id': 'D003625', 'term': 'Data Collection'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'blood saliva'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2014-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2026-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-07', 'studyFirstSubmitDate': '2014-03-26', 'studyFirstSubmitQcDate': '2014-03-26', 'lastUpdatePostDateStruct': {'date': '2025-07-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-03-31', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'creation of a Germ Cell Tumor and testicular tumor registry', 'timeFrame': '5 years', 'description': 'We will collect clinical data including diagnosis date, pathology, family history, and risk factors in patients with GCT-TT.'}]}, 'conditionsModule': {'keywords': ['14-016'], 'conditions': ['Germ Cell Tumor', 'Testicular Tumor']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.mskcc.org/', 'label': 'Memorial Sloan Kettering Cancer Center'}]}, 'descriptionModule': {'briefSummary': "This study is being done to create a registry to help us learn more about germ cell tumors (GCT) and other testicular tumors. The registry will include people with these tumors and also relatives and unrelated people without these tumors. This study will help us learn more about the prevention, diagnosis, treatment and outcome of these tumors. Studying relatives of patients and people unrelated to patients with GCT and other testicular tumors will help us understand why some people get these tumors and why some people don't."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'At MSKCC, the following outpatient clinics will be used to recruit GCT and testicular tumor cases and controls: Urology (Department of Surgery), Gynecologic Oncology (Department of Surgery) Clinical Genetics, Genitourinary Oncology (Department of Medicine), and Gynecologic Medical Oncology (Department of Medicine).', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nCase Cohort\n\n* Must be ≥ 18 years of age AND\n* Must be an English-speaker AND\n* Must have a diagnosis or suspicion of germ cell tumor and/or a testicular mass\n\nFamily Member Cohort\n\n* Must be ≥ 18 years of age AND\n* Must be an English-speaker AND\n* Must be a blood relative of the proband. Family members of probands are eligible. These individuals need not have a diagnosis of GCT-TT, as they will be used for segregation analysis of suspected variants found in the proband.\n\nControl Cohort\n\n* Must be ≥ 18 years of age AND\n* Must be an English-speaker AND\n* Must not have a personal history of cancer, with the exception of non-melanoma skin cancer, AND\n* Must not have a family history of germ cell tumor or testicular tumor AND\n* Must not be a blood relative of controls enrolled in this study\n\nExclusion Criteria:'}, 'identificationModule': {'nctId': 'NCT02099734', 'briefTitle': 'Germ Cell Tumor and Testicular Tumor DNA Registry', 'organization': {'class': 'OTHER', 'fullName': 'Memorial Sloan Kettering Cancer Center'}, 'officialTitle': 'Germ Cell Tumor and Testicular Tumor DNA Registry', 'orgStudyIdInfo': {'id': '14-016'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'A: suspicion of germ cell tumor and/or a testicular mass', 'description': 'patients with testicular GCTs and non-GCT testicular tumors, extragonadal male GCTs, and female GCTs,', 'interventionNames': ['Behavioral: Questionnaires', 'Other: sample of blood or saliva']}, {'label': 'B: family members of Group A', 'description': 'relatives of patients with GCTs or testicular tumors', 'interventionNames': ['Behavioral: Questionnaires', 'Other: sample of blood or saliva']}, {'label': 'C: healthy controls unrelated to Group A or B', 'description': 'healthy controls who are unrelated to Groups A or B and do not have a personal history of cancer nor a family history of GCT or non-GCT testicular tumors', 'interventionNames': ['Behavioral: Questionnaires', 'Other: sample of blood or saliva']}], 'interventions': [{'name': 'Questionnaires', 'type': 'BEHAVIORAL', 'armGroupLabels': ['A: suspicion of germ cell tumor and/or a testicular mass', 'B: family members of Group A', 'C: healthy controls unrelated to Group A or B']}, {'name': 'sample of blood or saliva', 'type': 'OTHER', 'description': 'A sample of blood or saliva will be obtained for DNA extraction. Approximately 2-4 tubes of blood will be collected or one tablespoon of saliva. If a participant has already provided a DNA sample for another MSKCC IRB approved protocol, they may not need to provide an additional sample.', 'armGroupLabels': ['A: suspicion of germ cell tumor and/or a testicular mass', 'B: family members of Group A', 'C: healthy controls unrelated to Group A or B']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Basking Ridge', 'state': 'New Jersey', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Darren Feldman, MD', 'role': 'CONTACT', 'phone': '646-422-4491'}], 'facility': 'Memorial Sloan Kettering Basking Ridge', 'geoPoint': {'lat': 40.70621, 'lon': -74.54932}}, {'zip': '07748', 'city': 'Middletown', 'state': 'New Jersey', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Darren Feldman, MD', 'role': 'CONTACT', 'phone': '646-422-4491'}], 'facility': 'Memorial Sloan Kettering Monmouth', 'geoPoint': {'lat': 40.39428, 'lon': -74.11709}}, {'zip': '07645', 'city': 'Montvale', 'state': 'New Jersey', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Darren Feldman, MD', 'role': 'CONTACT', 'phone': '646-422-4491'}], 'facility': 'Memorial Sloan Kettering Bergen', 'geoPoint': {'lat': 41.04676, 'lon': -74.02292}}, {'zip': '11724', 'city': 'Cold Spring Harbor', 'state': 'New York', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Richard McCombie, PhD', 'role': 'CONTACT', 'phone': '516-367-8800'}], 'facility': 'Cold Springs Harbor Laboratory (Specimen Analysis)', 'geoPoint': {'lat': 40.87149, 'lon': -73.45679}}, {'zip': '11725', 'city': 'Commack', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Darren Feldman, MD', 'role': 'CONTACT', 'phone': '646-422-4491'}], 'facility': 'Memorial Sloan Kettering Commack', 'geoPoint': {'lat': 40.84288, 'lon': -73.29289}}, {'zip': '10604', 'city': 'Harrison', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Darren Feldman, MD', 'role': 'CONTACT', 'phone': '646-422-4491'}], 'facility': 'Memorial Sloan Kettering Westchester', 'geoPoint': {'lat': 40.96899, 'lon': -73.71263}}, {'zip': '10065', 'city': 'New York', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Darren Feldman, MD', 'role': 'CONTACT', 'phone': '646-422-4491'}, {'name': 'Joel Sheinfeld, MD', 'role': 'CONTACT', 'phone': '646-422-4311'}, {'name': 'Darren Feldman, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Memorial Sloan Kettering Cancer Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '11553', 'city': 'Uniondale', 'state': 'New York', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Darren Feldman, MD', 'role': 'CONTACT', 'phone': '646-422-4491'}], 'facility': 'Memorial Sloan Kettering Nassau', 'geoPoint': {'lat': 40.70038, 'lon': -73.59291}}], 'centralContacts': [{'name': 'Darren Feldman, MD', 'role': 'CONTACT', 'phone': '646-422-4491'}, {'name': 'Joel Sheinfeld, MD', 'role': 'CONTACT', 'phone': '646-422-4311'}], 'overallOfficials': [{'name': 'Darren Feldman, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Memorial Sloan Kettering Cancer Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Memorial Sloan Kettering Cancer Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}