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NCT Number: NCT05564026

Molecular Epidemiology of Pediatric Germ Cell Tumors

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.

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Key information

Conditions

Germ Cell Tumor Adenocarcinoma Carcinoma Carcinoma, Embryonal Choriocarcinoma Embryonal Carcinoma Endodermal Sinus Tumor Female Urogenital Diseases and Pregnancy Complications Germinoma Late Effects Mesonephroma Mixed Germ Cell Tumor Neoplasms Neoplasms by Histologic Type Neoplasms, Germ Cell and Embryonal Neoplasms, Glandular and Epithelial Pediatric Germ Cell Tumor Pregnancy Complications Pregnancy Complications, Neoplastic Teratoma Trophoblastic Neoplasms Urogenital Diseases Yolk Sac Tumor

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location status: Recruiting

Location contact

Jenny Poynter, PhD

CONTACT

[email protected]

612-625-4232

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Questionnaire Administration

Other

Questionnaire provide to participant's about their health and quality of life since treatment

Tumor Specimen Collection

Other

Tumor DNA requested from the Biopathology Center

Germline DNA Samples

Other

Germline DNA specimens requested from the Biopathology Center or newly collected saliva

blood sample collection

Procedure

Collection and storing of serum/plasma

Primary outcomes

  1. Ototoxicity

    Time frame: Up 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.

  2. Somatic Mutations

    Time frame: Up 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.

  3. Methylation

    Time frame: Up 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Jenny Poynter

CONTACT

[email protected]

(612) 625-4232

Sponsors and collaborators

Lead sponsor

Children's Oncology Group

Network

Registry information

Official study title

Pediatric Germ Cell Tumors: Outcomes, Genomics and Epigenetics

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
Oct 3, 2022
Registry last updated
Oct 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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