Trials / Completed
CompletedNCT01434355
DNA Analysis in Samples From Younger Patients With Germ Cell Tumors and Their Parents or Siblings
Molecular Epidemiology of Pediatric Germ Cell Tumors
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 932 (estimated)
- Sponsor
- Children's Oncology Group · Network
- Sex
- All
- Age
- 19 Years
- Healthy volunteers
- Not accepted
Summary
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.
Detailed description
OBJECTIVES: I. To evaluate associations between genetic variation and pediatric germ cell tumor (GCT) using a case-parent triad design to identify variants in four genes, KITLG, SPRY4, BAK1, and DMRT1, associated with pediatric GCT. II. To evaluate associations between genetic variation and pediatric GCT using a case-parent triad design to include targeted genotyping of single nucleotide polymorphisms (SNPs) in selected key pathways essential for normal in utero germ cell development, specifically genes involved in survival of germ cells during migration, apoptosis, and cell cycle control. III. To explore inter- and intratumoral heterogeneity in DNA methylation by tumor histology. OUTLINE: This is a multicenter study. 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 polymerasechain reaction (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.
Conditions
- Childhood Malignant Ovarian Germ Cell Tumor
- Childhood Malignant Testicular Germ Cell Tumor
- Ovarian Choriocarcinoma
- Ovarian Embryonal Carcinoma
- Ovarian Mixed Germ Cell Tumor
- Ovarian Teratoma
- Ovarian Yolk Sac Tumor
- Testicular Choriocarcinoma
- Testicular Embryonal Carcinoma
- Testicular Seminoma
- Testicular Teratoma
- Testicular Yolk Sac Tumor
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | Laboratory Biomarker Analysis | Correlative studies |
| OTHER | Questionnaire Administration | Ancillary studies |
Timeline
- Start date
- 2011-11-01
- Primary completion
- 2016-08-04
- Completion
- 2016-08-04
- First posted
- 2011-09-14
- Last updated
- 2019-01-07
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT01434355. Inclusion in this directory is not an endorsement.