Molecular Epidemiology of Pediatric Germ Cell Tumors
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Detailed Description
PRIMARY OBJECTIVES:
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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.
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Compare somatic variation by tumor histology to identify molecular signatures that improve prognostic risk stratification.
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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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 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. |
Other: Questionnaire Administration
Questionnaire provide to participant's about their health and quality of life since treatment
Other: Tumor Specimen Collection
Tumor DNA requested from the Biopathology Center
Other: Germline DNA Samples
Germline DNA specimens requested from the Biopathology Center or newly collected saliva
Procedure: Blood Sample Collection
Collection and storing of serum/plasma
|
Outcome Measures
Primary Outcome Measures
- Ototoxicity [Up to 5 years]
Ototoxicity as determined by review of end of therapy audiograms will serve as the primary outcome variable for analyses. Results from the app-based hearing assessment will be used to identify survivors with hearing loss that has developed or progressed since the completion of therapy
- Somatic Mutations [Up to 5 years]
Compare somatic variation by tumor histology to identify molecular signatures that improve prognostic risk stratification
- Methylation [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.
Eligibility Criteria
Criteria
Inclusion Criteria:
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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.
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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.
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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.
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Participants must be able to complete study related documents in English or Spanish.
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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.
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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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of Minnesota | Minneapolis | Minnesota | United States | 55455 |
Sponsors and Collaborators
- Children's Oncology Group
Investigators
- Principal Investigator: Jenny Poynter, PhD, Children's Oncology Group
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- AEPI17N3