Studying Biomarkers in Samples From Younger Patients With Malignant Germ Cell Tumor Progression
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|ClinicalTrials.gov Identifier: NCT01433224|
Recruitment Status : Completed
First Posted : September 13, 2011
Last Update Posted : May 18, 2016
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|
|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|
- 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 Type :||Observational|
|Estimated Enrollment :||90 participants|
|Official Title:||Genomic Signatures of Malignant Germ Cell Tumor Progression: A Retrospective Study of Banked Specimens|
|Study Start Date :||October 2011|
|Actual Primary Completion Date :||May 2016|
|Actual Study Completion Date :||May 2016|
- Event-free survival
- Genomic prognostic signatures associated with GCTS
- Genetic variants that contribute to GCTS pathogenesis
- Expression of various forms of RNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01433224
|Principal Investigator:||James F. Amatruda, MD, PhD||Simmons Cancer Center|