What this study is
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.
What's being tested
- Questionnaire Administration
Intervention · OTHER
Questionnaire provide to participant's about their health and quality of life since treatment
- Tumor Specimen Collection
Intervention · OTHER
Tumor DNA requested from the Biopathology Center
- Germline DNA Samples
Intervention · OTHER
Germline DNA specimens requested from the Biopathology Center or newly collected saliva
- Blood Sample Collection
Intervention · PROCEDURE
Collection and storing of serum/plasma
Study details
- Official title
- Pediatric Germ Cell Tumors: Outcomes, Genomics and Epigenetics
- Sponsor
- Children's Oncology Group
- Conditions
- Germ Cell Tumor · Germinoma · Teratoma · Embryonal Carcinoma · Yolk Sac Tumor · Choriocarcinoma · Mixed Germ Cell Tumor · Late Effects · Pediatric Germ Cell Tumor
- Enrolling
- 1,151 people
- Starts
- 2023-04-12
- Est. completion
- 2027-06-30
- Record
- View on ClinicalTrials.gov ↗
Who can join
Sex ALLHealthy volunteers Not acceptedYou may qualify if
- 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.
You can't join if
- 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
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openUniversity of Minnesota
Minneapolis, Minnesota, United States
- Jenny Poynter, PhD · Contact612-625-4232poynt006@umn.edu
Recruiting
Study team
Sponsor
Children's Oncology Group
Study ID AEPI17N3
Principal investigator
Jenny Poynter, PhD
Children's Oncology Group
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.