NCT05564026 Molecular Epidemiology of Pediatric Germ Cell Tumors
| NCT ID | NCT05564026 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Children's Oncology Group |
| Condition | Germ Cell Tumor |
| Study Type | OBSERVATIONAL |
| Enrollment | 1,151 participants |
| Start Date | 2023-04-12 |
| Primary Completion | 2027-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 1,151 participants in total. It began in 2023-04-12 with a primary completion date of 2027-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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
Contact & Investigator
Jenny Poynter, PhD
PRINCIPAL INVESTIGATOR
Children's Oncology Group
Frequently Asked Questions
Who can join the NCT05564026 clinical trial?
This trial is open to participants of all sexes, studying Germ Cell Tumor. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05564026 currently recruiting?
Yes, NCT05564026 is actively recruiting participants. Contact the research team at poynt006@umn.edu for enrollment information.
Where is the NCT05564026 trial being conducted?
This trial is being conducted at Minneapolis, United States.
Who is sponsoring the NCT05564026 clinical trial?
NCT05564026 is sponsored by Children's Oncology Group. The principal investigator is Jenny Poynter, PhD at Children's Oncology Group. The trial plans to enroll 1,151 participants.