Clinical trial · Observational
DNA Analysis in Samples From Younger Patients With Germ Cell Tumors and Their Parents or Siblings
Molecular Epidemiology of Pediatric Germ Cell Tumors
NCT01434355CI-TRIAL-00036366completedClinicalTrials.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)
This research trial studies deoxyribonucleic acid (DNA) samples from younger patients with germ cell tumor and their parents or siblings. Studying samples of tumor tissue and saliva from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.
Conditions
Conditions (12)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Childhood Malignant Ovarian Germ Cell Tumor | Childhood Malignant Ovarian Germ Cell Tumor | ONTOLOGY_EXACT | 0.98 |
| Childhood Malignant Testicular Germ Cell Tumor | Childhood Malignant Testicular Germ Cell Tumor | ONTOLOGY_EXACT | 0.98 |
| Ovarian Choriocarcinoma | Ovarian Choriocarcinoma | ONTOLOGY_EXACT | 0.98 |
| Ovarian Embryonal Carcinoma | Ovarian Embryonal Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Ovarian Mixed Germ Cell Tumor | Ovarian Mixed Germ Cell Tumor | ONTOLOGY_EXACT | 0.98 |
| Ovarian Teratoma | Ovarian Teratoma | ONTOLOGY_EXACT | 0.98 |
| Ovarian Yolk Sac Tumor | Ovarian Yolk Sac Tumor | ONTOLOGY_EXACT | 0.98 |
| Testicular Choriocarcinoma | Testicular Choriocarcinoma | ONTOLOGY_EXACT |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Laboratory Biomarker Analysis | Other | — | UNRESOLVED |
| Questionnaire Administration | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Correlative studies
- description
- Patients and parents or siblings undergo saliva sample collection. DNA extracted from saliva samples and from patients' archived tumor tissue samples is genotyped and analyzed by methylation arrays, including methylation-specific PCR (pyrosequencing) assays. Genetic variation between pediatric germ cell tumors and parent or sibling is also analyzed. Patients' and family members' health history, demographics, and environmental exposures are collected by questionnaires or telephone interviews. Medical history, such as chronic conditions, prescribed medications and congenital abnormalities, including cryptorchidism, is also collected. Birth characteristics of the child, including birth weight and gestational age, are also captured.
- interventionNames
- Other: Laboratory Biomarker Analysis
- Other: Questionnaire Administration
Primary outcomes (1)
- measure
- Pediatric GCT associated with genetic susceptibility
- timeFrame
- Up to 5 years
- description
- Will be modeled using a Poisson regression. A likelihood ratio test determines the statistical significance.
Secondary outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- All
- Maximum age
- 19 Years
Show eligibility criteria text
Inclusion Criteria: * The patient is enrolled on COG-ACCRN07 * The patient has a primary diagnosis of germ cell tumor (GCT) including germinoma (ICCC 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 and central nervous system and registered with Children's Oncology Group (COG) by a North American member institution * The patient must be diagnosed with a germ cell tumor between July 1, 2008 and December 31, 2015 * The patient must be \< 20 years of age at the time of diagnosis * The patient must have at least one biological parent alive and willing to participate * In the event that one case parent cannot contribute DNA, a case sibling, defined as the biological brother or sister of the study subject, may donate instead * All questionnaire respondents must understand English or Spanish * Concomitant treatment on a therapeutic trial is not required
References
Publications (0)
Data not yet available
No reference posted for this study.