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.
Full Title of Study: “Ex Vivo Gene Expression Profiling of Cervical Cancer Progression in Biopsies And Tissue Samples From Patients With Cervical Lesions”
- Study Type: Interventional
- Study Design
- Allocation: N/A
- Intervention Model: Single Group Assignment
- Primary Purpose: Diagnostic
- Masking: None (Open Label)
- Study Primary Completion Date: June 2010
- 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.
- Genetic: microarray analysis
- Other: flow cytometry
- Procedure: biopsy
- Procedure: colposcopy
Clinical Trial Outcome Measures
- 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
Participating in This Clinical Trial
- Clinically suspicious malignant or premalignant cervical lesion
- Included subjects will be ≥18 years old.
- Included subjects will not be pregnant.
- Included subjects will have a negative urine pregnancy test.
- Included subjects will be scheduled for colposcopy and/or LEEP treatment at the VGH Women's Clinic.
- Included subjects will indicate understanding of the study.
- Included subjects will provide informed consent to participate.
- Individuals <18 years old will be excluded.
- Pregnant individuals will be excluded.
- Individuals that have had an operation to remove their cervix will be excluded.
Gender Eligibility: Female
Minimum Age: 19 Years
Maximum Age: N/A
Are Healthy Volunteers Accepted: No
- Lead Sponsor
- British Columbia Cancer Agency
- National Cancer Institute (NCI)
- Provider of Information About this Clinical Study
- Overall Official(s)
- Thomas G Ehlen, M.D., Principal Investigator, BC Cancer Agency, Vancouver General Hospital
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