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NCT05564026 | RECRUITING | Germ Cell Tumor

Molecular Epidemiology of Pediatric Germ Cell Tumors
Sponsor:

Children's Oncology Group

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.

Condition or disease

Germ Cell Tumor

Germinoma

Teratoma

Embryonal Carcinoma

Yolk sac tumor

Choriocarcinoma

Mixed Germ Cell Tumor

Late Effects

Pediatric Germ Cell Tumor

Intervention/treatment

Questionnaire Administration

Tumor Specimen Collection

Germline DNA Samples

Blood Sample Collection

Detailed Description:

PRIMARY OBJECTIVES: I. Establish a survivorship cohort for pediatric and adolescent GCT comprised of participants from AEPI10N1 and APEC14B1 to assess short term and long-term adverse events associated with GCT treatment. II. Compare somatic variation by tumor histology to identify molecular signatures that improve prognostic risk stratification. III. Identify methylation patterns that predict poor clinical outcomes, including disease relapse and death. OUTLINE: Medical records from pediatric and adolescent Germ Cell Tumor (GCT) participants from AEPI10N1 and APEC14B1 will be used to obtain treatment information and validate self-reported outcomes. Paired normal and tumor samples will be used to evaluate single nucleotide variants, indels, copy number variations, and DNA methylation patterns. Ototoxicity will be determined by central review of audiogram files obtained from the treating institutions and self-reported based on questionnaire data.

Study Type : OBSERVATIONAL
Estimated Enrollment : 1151 participants
Official Title : Pediatric Germ Cell Tumors: Outcomes, Genomics and Epigenetics
Actual Study Start Date : 2023-04-12
Estimated Primary Completion Date : 2027-06-30
Estimated Study Completion Date : 2027-06-30

Information not available for Arms and Intervention/treatment

Ages Eligible for Study:
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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
Molecular Epidemiology of Pediatric Germ Cell Tumors

Location Details

NCT05564026

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How to Participate

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Locations

RECRUITING

United States, Minnesota

The University of Minnesota

Minneapolis, Minnesota, United States, 55455