Clinical trial · Observational
Molecular Epidemiology of Pediatric Germ Cell Tumors
Pediatric Germ Cell Tumors: Outcomes, Genomics and Epigenetics
NCT05564026CI-TRIAL-00096776recruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (9)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Choriocarcinoma | Choriocarcinoma | ONTOLOGY_EXACT | 0.90 |
| Embryonal Carcinoma | Embryonal Carcinoma | ONTOLOGY_EXACT | 0.90 |
| Germ Cell Tumor | Germ Cell Tumor | ONTOLOGY_EXACT | 0.90 |
| Germinoma | Germinoma | ONTOLOGY_EXACT | 0.90 |
| Late Effects | — | UNRESOLVED | — |
| Mixed Germ Cell Tumor | Mixed Germ Cell Tumor | ONTOLOGY_EXACT | 0.90 |
| Pediatric Germ Cell Tumor | Childhood Germ Cell Tumor | ALIAS | 0.90 |
| Teratoma | Teratoma | ONTOLOGY_EXACT | 0.90 |
| Yolk Sac Tumor | Yolk Sac Tumor | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Blood Sample Collection | Procedure | — | UNRESOLVED |
| Germline DNA Samples | Other | — | UNRESOLVED |
| Questionnaire Administration | Other | — | UNRESOLVED |
| Tumor Specimen Collection | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Ancillary-Correlative
- description
- 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.
- interventionNames
- Other: Questionnaire Administration
- Other: Tumor Specimen Collection
- Other: Germline DNA Samples
- Procedure: Blood Sample Collection
Primary outcomes (3)
- measure
- Ototoxicity
- timeFrame
- Up to 5 years
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.