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

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

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

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 Summary:

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.


Sponsor: Children's Oncology Group

Current Primary Outcome:

  • Event-free survival
  • Genomic prognostic signatures associated with GCTS
  • Genetic variants that contribute to GCTS pathogenesis
  • Expression of various forms of RNA


Original Primary Outcome:

  • Event-free survival
  • Genomic prognostic signatures associated with GCTS
  • Genetic variants that contribute to GCTS pathogenesis


Current Secondary Outcome:

Original Secondary Outcome:

Information By: Children's Oncology Group

Dates:
Date Received: September 9, 2011
Date Started: October 2011
Date Completion:
Last Updated: May 17, 2016
Last Verified: May 2016