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Molecular Epidemiology of Pediatric Germ Cell Tumors
RECRUITINGSponsored by Children's Oncology Group
Actively Recruiting
SponsorChildren's Oncology Group
Started2023-04-12
Est. completion2027-06-30
Locations1 site
View on ClinicalTrials.gov →
NCT05564026
Summary
A Non-Therapeutic Study that aims to establish a cohort of GCT survivors to understand short term and long-term adverse effects of treatment and to conduct molecular analyses to improve risk stratification.
Eligibility
Inclusion Criteria: * Cases will be eligible for the study if they have a primary diagnosis of GCT including germinoma (ICCC code105 9060-9065), teratoma (9080-9084), embryonal carcinoma (9070-9072), yolk sac tumor (9071), choriocarcinoma (9100, 9103, 9104), and mixed GCT (9085, 9101, 9102, 9105) in all sites including the brain. * The patient must be enrolled on APEC14B1 with consent to future contact or enrolled in AEPI10N1 with consent for future contact (N=827). Patients enrolled in AEPI10N1 were recruited from ACCRN07. All patients must be registered with COG by a North American member institution. Note: (history of) treatment on a COG therapeutic trial is not required. * Patients must be diagnosed at \< 20 years of age at the time of GCT diagnosis. Study participants will be followed over time in the survivorship study so there is no maximum age for participation. * Participants must be able to complete study related documents in English or Spanish. * All patients and/or their parents or legal guardians must provide informed consent. Assent will be obtained for participants between the ages of 8-17 years. * All institutional, FDA, and NCI requirements for human studies must be met. Exclusion Criteria: * Participants from AEPI10N1 who did not consent to future contact. Patients who do not meet the eligibility criteria described above or cannot complete study materials in English or Spanish
Conditions10
CancerChoriocarcinomaEmbryonal CarcinomaGerm Cell TumorGerminomaLate EffectsMixed Germ Cell TumorPediatric Germ Cell TumorTeratomaYolk Sac Tumor
Locations1 site
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Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.
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Actively Recruiting
SponsorChildren's Oncology Group
Started2023-04-12
Est. completion2027-06-30
Locations1 site
View on ClinicalTrials.gov →
NCT05564026