NCT01433224

Studying Biomarkers in Samples From Younger Patients With Malignant Germ Cell Tumor Progression

Genomic Signatures of Malignant Germ Cell Tumor Progression: A Retrospective Study of Banked Specimens

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 90 (estimated)
• Sponsor: Children's Oncology Group · Network
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

RATIONALE: Studying samples of blood and tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. It may also help doctors find better ways to treat cancer. PURPOSE: This research trial studies samples from younger patients with malignant germ cell tumor progression.

Detailed description

OBJECTIVES: * Explore inter-tumoral heterogeneity in DNA methylation by tumor histology. * Determine the genomic methylation pattern in the tumors. * Correlate methylation pattern with tumor histology and clinical characteristics. * Carry out exome capture and massively parallel sequencing on selected germ cell tumors (GCTs) and matched normal tissue. * Perform exome capture and Solexa sequencing on a selected set of GCTs. * Validate candidate mutations in an independent set of tumors. * Determine the expression profile of mRNAs, lincRNAs and microRNAs in the tumors using RNA Seq. OUTLINE: Archived blood and tumor tissue samples are analyzed for genomic methylation pattern, exome capture and sequencing, and candidate mutations by methylation-specific PCR techniques, single nucleotide polymorphism (SNP) arrays, and Solexa sequencing methods. Results are validated by using pyrosequencing assays and primer-extension assays. Methylation pattern is also associated with each patient's tumor histology and clinical data.

Conditions

• Childhood Germ Cell Tumor
• Extragonadal Germ Cell Tumor
• Ovarian Cancer
• Testicular Germ Cell Tumor

Interventions

Type	Name	Description
GENETIC	DNA methylation analysis
GENETIC	RNA analysis
GENETIC	mutation analysis
GENETIC	nucleic acid sequencing
GENETIC	polymerase chain reaction
GENETIC	polymorphism analysis
OTHER	laboratory biomarker analysis
OTHER	medical chart review

Timeline

• Start date: 2011-10-01
• Primary completion: 2016-05-01
• Completion: 2016-05-01
• First posted: 2011-09-13
• Last updated: 2016-05-18