Studying Biomarkers in Samples From Younger Patients With Malignant Germ Cell Tumor Progression
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.
Childhood Germ Cell Tumor
Extragonadal Germ Cell Tumor
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
|Study Design:||Observational Model: Case-Only
Time Perspective: Retrospective
|Official Title:||Genomic Signatures of Malignant Germ Cell Tumor Progression: A Retrospective Study of Banked Specimens|
- Event-free survival [ Designated as safety issue: No ]
- Genomic prognostic signatures associated with GCTS [ Designated as safety issue: No ]
- Genetic variants that contribute to GCTS pathogenesis [ Designated as safety issue: No ]
- Expression of various forms of RNA [ Designated as safety issue: No ]
|Study Start Date:||October 2011|
|Study Completion Date:||May 2016|
|Primary Completion Date:||May 2016 (Final data collection date for primary outcome measure)|
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01433224
|Principal Investigator:||James F. Amatruda, MD, PhD||Simmons Cancer Center|