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Understanding Pediatric Germ Cell Tumors

This study, called "Molecular Epidemiology of Pediatric Germ Cell Tumors," is an observational study that aims to understand more about germ cell tumors (GCTs) in children and adolescents. It's not testing a new treatment, but rather collecting information to improve care. Researchers will gather information from medical records and analyze tumor and blood samples to learn about the short-term and long-term effects of GCT treatment. They will also look for specific genetic changes in tumors and patterns in DNA that might help predict how a tumor will behave. This study is open to all ages and genders who have been diagnosed with a GCT, including germinoma, teratoma, embryonal carcinoma, or yolk sac tumor. The goal is to identify factors that can help doctors better understand and treat these cancers.

Study design
This is an observational study planning to enroll 1151 participants. It is not testing a specific drug or treatment.
What's involved
Participants may be asked to complete questionnaires about their health and quality of life. Tumor and germline DNA samples, as well as blood samples, may be collected.
Compensation
Not stated in the trial record.
Follow-up
Ototoxicity (hearing problems), somatic mutations (changes in tumor DNA), and methylation patterns will be measured for up to 5 years.

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NCT05564026

Molecular Epidemiology of Pediatric Germ Cell Tumors

Recruiting
Not specifiedAll AgesObservational
Children's Oncology Group
~1,151 participants
Updated 2025-10-24 on ClinicalTrials.gov
What's tested:Questionnaire AdministrationTumor Specimen CollectionGermline DNA SamplesBlood Sample Collection

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Ototoxicity
Measured over Up to 5 years
+2 more outcomes measured

Conditions

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

Explore related trials

ChoriocarcinomaEmbryonal CarcinomaGerm Cell TumorGerminomaMixed Germ Cell TumorTeratomaYolk Sac Tumor

Where it's being run

1 sites across 1 states
Minnesota1

Study leadership

  • Jenny Poynter, PhD · PRINCIPAL_INVESTIGATOR · Children's Oncology Group

Who to contact

Jenny Poynter
[email protected]
(612) 625-4232
Email the study team

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • OtotoxicityUp to 5 years

    Ototoxicity as determined by central review of end of therapy audiograms will serve as the primary outcome variable for analyses. Current ototoxicity will be assessed using an app-based hearing assessment. For the app-based audiometry assessment, unilateral hearing loss will be defined as at least one pure tone threshold greater than 25 decibels across at any one of the frequencies from 2,000 Hz- 8,000 Hz to align with the SIOP Boston guidelines, while bilateral hearing loss will be defined as a pure tone threshold \> 25 decibels in both ears at any one of the frequencies.

  • Somatic MutationsUp to 5 years

    Compare somatic variation by tumor histology to identify molecular signatures that improve prognostic risk stratification. Somatic mutations will be identified by comparing tumor samples to normal samples. Risk stratification will be based on event free survival, defined as the time from diagnosis to relapse or death.

  • MethylationUp to 5 years

    Compare the association between DNA methylation patterns and relapse or death. Mixed-effects regression models will be used to test for association between methylation beta values and poor outcomes. The outcome will be defined as a binary variable with a value of one if the patient experienced a relapse or death event and zero otherwise.