Gene Expression Profiling of Cervical Cancer Progression in Biopsies and Tissue Samples (SAGE)
|ClinicalTrials.gov Identifier: NCT00629577|
Recruitment Status : Terminated (no funding)
First Posted : March 6, 2008
Last Update Posted : February 1, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Cervical Cancer Precancerous Condition||Genetic: microarray analysis Other: flow cytometry Procedure: biopsy Procedure: colposcopy||Phase 1|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Ex Vivo Gene Expression Profiling of Cervical Cancer Progression in Biopsies And Tissue Samples From Patients With Cervical Lesions|
|Study Start Date :||September 2006|
|Actual Primary Completion Date :||June 2010|
|Actual Study Completion Date :||December 2011|
- Classification of cervical cancer progression at a molecular level using gene expression profiling
- Gene expression changes by microarray
- Set of genes that classify the various grades of cervical cancer/dysplasia
- Comparison of the expression profiles of clinical data to determine how accurately cell lines model the in vivo environment
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): 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|