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Clinical Trials/NCT01433224
NCT01433224
Completed
Not Applicable

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

Children's Oncology Group0 sites90 target enrollmentStarted: October 2011Last updated:

Overview

Phase
Not Applicable
Status
Completed
Enrollment
90
Primary Endpoint
Event-free survival

Overview

Brief 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.

Study Design

Study Type
Observational
Observational Model
Case Only
Time Perspective
Retrospective

Eligibility Criteria

Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Event-free survival

Genomic prognostic signatures associated with GCTS

Genetic variants that contribute to GCTS pathogenesis

Expression of various forms of RNA

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Network
Responsible Party
Sponsor

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