Clinical trial NCT05564026: Molecular Epidemiology of Pediatric Germ Cell Tumors
Official title: Pediatric Germ Cell Tumors: Outcomes, Genomics and Epigenetics
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Germ Cell Tumor
Germinoma
Teratoma
Embryonal Carcinoma
Yolk Sac Tumor
Choriocarcinoma
Mixed Germ Cell Tumor
Late Effects
Pediatric Germ Cell Tumor
Lead sponsor: Children's Oncology Group
Sponsor class: NETWORK
First posted: 2022-10-03
Enrollment: 1151
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: FAMILY_BASED
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pediatric and adolescent Germ Cell Tumor survivors recruited from recently completed Children's Oncology Group (COG) epidemiology study (AEPI10N1) and the COG Project:EveryChild Registry (APEC14B1).

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.

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.

Eligibility 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

Primary outcomes:
measure: Ototoxicity
timeFrame: Up to 5 years
measure: Somatic Mutations
timeFrame: Up to 5 years
measure: Methylation
timeFrame: Up to 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
Study officials:
affiliation: Children's Oncology Group
name: Jenny Poynter, PhD
role: PRINCIPAL_INVESTIGATOR
References: