Understanding the long-term effects of pediatric germ cell tumors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.