NCT Number: NCT01433224
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.
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Notify MeKey information
Conditions
Sex eligibility
All sexes
Study type
Observational
About this study
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.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
PATIENT CHARACTERISTICS:
- Not specified
PRIOR CONCURRENT THERAPY:
- Not specified
Treatment and study plan
RNA analysis
Geneticmutation analysis
Geneticnucleic acid sequencing
Geneticpolymerase chain reaction
Geneticpolymorphism analysis
Geneticlaboratory biomarker analysis
Othermedical chart review
OtherPrimary outcomes
-
Event-free survival
-
Genomic prognostic signatures associated with GCTS
-
Genetic variants that contribute to GCTS pathogenesis
-
Expression of various forms of RNA
Sponsors and collaborators
Lead sponsor
Children's Oncology Group
Network
Collaborators
- National Cancer Institute (NCI)
Registry information
Official study title
Genomic Signatures of Malignant Germ Cell Tumor Progression: A Retrospective Study of Banked Specimens
Important dates
- Study start
- 2011
- Primary completion
- 2016
- Study completion
- 2016
- First posted
- Sep 13, 2011
- Registry last updated
- May 18, 2016
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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