Pediatric Germ Cell Tumors: Outcomes, Genomics and Epigenetics

Status: Recruiting
Location: See location...
Intervention Type: Procedure, Other
Study Type: Observational
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
Participation Requirements
Sex: All
Healthy Volunteers: f
View:

• 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.

Locations
United States
Minnesota
University of Minnesota
RECRUITING
Minneapolis
Contact Information
Primary
Jenny Poynter
poynt006@umn.edu
(612) 625-4232
Time Frame
Start Date: 2023-04-12
Estimated Completion Date: 2027-06-30
Participants
Target number of participants: 1151
Treatments
Ancillary-Correlative
Children and adolescents with a germ cell tumor, previously enrolled on APEC14B1 or AEPI10N1 who allow access to medical records (including audiograms), grant permission to: evaluate of all of their DNA, place their genetic and health information in scientific databanks, and collect a blood sample at a routine clinic/home visit, as well as complete a questionnaire about your health and quality of life since treatment.
Sponsors
Leads: Children's Oncology Group

This content was sourced from clinicaltrials.gov