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

Sponsor

Children's Oncology Group (Other)

Overall Status

Completed

CT.gov ID

NCT01433224

Collaborator

National Cancer Institute (NCI) (NIH)

Enrollment

Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Childhood Germ Cell Tumor Extragonadal Germ Cell Tumor Ovarian Cancer Testicular Germ Cell Tumor	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

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

Anticipated Enrollment :

90 participants

Observational Model:

Case-Only

Time Perspective:

Retrospective

Official Title:

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

Study Start Date :

Oct 1, 2011

Actual Primary Completion Date :

May 1, 2016

Actual Study Completion Date :

May 1, 2016

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

DISEASE CHARACTERISTICS:

Tumor and blood specimens from patients registered on the Children Oncology Group (COG) Germ Cell Tumor Protocols, and from other study sites for non-COG patients, including Children's Medical Center, Dallas and the Dana-Farber Cancer Institute, Boston
Patients' clinical data