Molecular Epidemiology of Pediatric Germ Cell Tumors

Part of paid clinical trials in Minneapolis, Minnesota.

Sponsor
Children's Oncology Group
Study ID
NCT05564026
Status
Recruiting
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Conditions

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

Eligibility Criteria

Sex
ALL
Age
N/A - N/A
Healthy Volunteers
Not accepted

Interventions

  • 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

Study Details

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.

Key Dates

Start date
Apr 12, 2023
Status verified
Sep 2025
Primary completion
Jun 30, 2027
Completion
Jun 30, 2027

Study Design

Enrollment
1,151 participants (estimated)

Arms

  • Arm: 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.

Primary Outcome Measure

Ototoxicity [ Time Frame: Up to 5 years ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of MinnesotaMinneapolisMinnesota55455
Jenny Poynter, PhD
[email protected]
612-625-4232

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By research site
University of Minnesota· Minneapolis, MN

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