Understanding the long-term effects of pediatric germ cell tumors
Pediatric Germ Cell Tumors: Outcomes, Genomics and Epigenetics
This study is trying to understand the long-term effects of treatment on kids and teens who survived germ cell tumors to see how their health might change over time.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1151 (estimated) |
| Sex | All |
| Sponsor | Children's Oncology Group Research network |
| Locations | 1 site (Minneapolis, Minnesota) |
| Trial ID | NCT05564026 on ClinicalTrials.gov |
What this trial studies
This observational study aims to establish a cohort of pediatric and adolescent survivors of germ cell tumors (GCT) to assess both short-term and long-term adverse effects of their treatment. It will analyze medical records and tumor samples to identify molecular signatures and methylation patterns that could improve risk stratification and predict clinical outcomes. Participants will be followed over time, and their treatment information will be validated through questionnaires and medical records. The study focuses on various types of GCT, including germinoma, teratoma, and yolk sac tumors.
Who should consider this trial
Good fit: Ideal candidates are pediatric and adolescent patients diagnosed with germ cell tumors before the age of 20 who have consented to future contact.
Not a fit: Patients who are not diagnosed with germ cell tumors or those who do not meet the age and consent criteria may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved risk stratification and better management of long-term health outcomes for pediatric GCT survivors.
How similar studies have performed: Other studies have shown success in understanding the long-term effects of cancer treatments in pediatric populations, making this approach promising.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Minneapolis, Minnesota
- University of Minnesota — Minneapolis, Minnesota, United States (Recruiting)
Study contacts
- Principal investigator: Jenny Poynter, PhD — Children's Oncology Group
- Study coordinator: Jenny Poynter
- Email: poynt006@umn.edu
- Phone: (612) 625-4232
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.