Gene Expression Profiling of Cervical Cancer Progression in Biopsies and Tissue Samples (SAGE)
RATIONALE: Studying samples of tumor 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.
PURPOSE: This research trial is studying gene expression profiling of cervical cancer progression in biopsies and tissue samples from patients with cervical lesions.
Genetic: microarray analysis
Other: flow cytometry
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
|Official Title:||Ex Vivo Gene Expression Profiling of Cervical Cancer Progression in Biopsies And Tissue Samples From Patients With Cervical Lesions|
- Classification of cervical cancer progression at a molecular level using gene expression profiling [ Designated as safety issue: No ]
- Gene expression changes by microarray [ Designated as safety issue: No ]
- Set of genes that classify the various grades of cervical cancer/dysplasia [ Designated as safety issue: No ]
- Comparison of the expression profiles of clinical data to determine how accurately cell lines model the in vivo environment [ Designated as safety issue: No ]
|Study Start Date:||September 2006|
|Estimated Study Completion Date:||December 2011|
|Estimated Primary Completion Date:||June 2010 (Final data collection date for primary outcome measure)|
- Classify cervical cancer progression at a molecular level using gene expression profiling generated from expression microarrays.
- Profile gene expression changes of dysplasia and early carcinoma of uterine cervical tissue at a molecular level using expression microarrays.
- Define a set of genes that classify the various grades of cervical cancer/dysplasia at a molecular level.
- Compare the expression profiles of clinical data to determine how accurately cell lines model the in vivo environment.
OUTLINE: Patients undergo colposcopy and a cervical smear is taken for flow cytometry analysis. Patients also undergo 2 biopsies from one clinically abnormal or normal site. Tissue samples are analyzed by gene expression profiling using human expression microarrays containing approximately 40,000 unique sequences. Data analysis consists of defining a set of genes, containing new targets for biomarkers, that classify the biopsies into 3 grades.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00629577
|Canada, British Columbia|
|BC Cancer Research Centre|
|Vancouver, British Columbia, Canada, V5Z 1L3|
|Principal Investigator:||Thomas G Ehlen, M.D.||BC Cancer Agency, Vancouver General Hospital|