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

Completed

• Conditions: Extragonadal Germ Cell Tumor; Testicular Germ Cell Tumor; Ovarian Cancer; Childhood Germ Cell Tumor

• Registration Number: NCT01433224
• Lead Sponsor: Children's Oncology Group

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 Timeline

• Study First Submitted: 2011-09-09
• Study First Submitted QC: 2011-09-09
• Study First Posted: 2011-09-13
• Study Start: 2011-10
• Status Verified: 2016-05
• Primary Completion: 2016-05
• Study Completion: 2016-05
• Last Update Submitted: 2016-05-17
• Last Update Posted: 2016-05-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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