Molecular Epidemiology of Pediatric Germ Cell Tumors

Children's Oncology Group

Status: Enrolling

Conditions: Germ Cell Tumor; Yolk Sac Tumor; Choriocarcinoma; Teratoma; Pediatric Germ Cell Tumor; Late Effects; Germinoma; Embryonal Carcinoma; Mixed Germ Cell Tumor

Treatments: Other: Germline DNA Samples; Procedure: Blood Sample Collection; Other: Tumor Specimen Collection; Other: Questionnaire Administration

Study type: Observational

Funder types: NETWORK

Identifiers

NCT05564026

AEPI17N3

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,151 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

1,151 participants in 1 patient group

Ancillary-Correlative

Description:

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.

Treatment:

Other: Questionnaire Administration

Other: Tumor Specimen Collection

Procedure: Blood Sample Collection

Other: Germline DNA Samples