Recruiting

Observational Study

Sponsor:

Children's Oncology Group

Code:

NCT05564026

Conditions

Germ Cell Tumor

Germinoma

Teratoma

Embryonal Carcinoma

Yolk Sac Tumor

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Interventions

Questionnaire Administration

Tumor Specimen Collection

Germline DNA Samples

Blood Sample Collection

Study Details

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.

Conditions

Germ Cell Tumor

Germinoma

Teratoma

Embryonal Carcinoma

Yolk Sac Tumor

Study ID

NCT05564026

Start date

Apr 12, 2023

Status verified date

Sep, 2025

Completion date

Jun 30, 2027

Anticipated

Primary completion date

Jun 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

1151 participants

Anticipated

Interventions and Outcome Measures

Arms

Ancillary-Correlative

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.

Interventions

Questionnaire Administration

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

Tumor Specimen Collection

Tumor DNA requested from the Biopathology Center

Germline DNA Samples

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

Blood Sample Collection

Collection and storing of serum/plasma

Primary outcome measure

  • Ototoxicity [ Time Frame: Up to 5 years ]
  • Somatic Mutations [ Time Frame: Up to 5 years ]
  • Methylation [ Time Frame: Up to 5 years ]

Central Contacts and Locations

Central contacts

Jenny Poynter

(612) 625-4232poynt006@umn.edu

Locations

University of Minnesota

Recruiting

Minneapolis, Minnesota, United States, 55455

Contacts

Jenny Poynter, PhD

612-625-4232poynt006@umn.edu

More Information

Sponsor

Children's Oncology Group

Last update posted

Oct 24, 2025

Last verified

Sep, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Children's Oncology Group on 2025-10-24.