Gene Expression Profiling of Cervical Cancer Progression in Biopsies and Tissue Samples

Study Overview
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Brief Summary
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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.

Detailed Description
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OBJECTIVES: 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.

Official Title
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Ex Vivo Gene Expression Profiling of Cervical Cancer Progression in Biopsies And Tissue Samples From Patients With Cervical Lesions

Conditions
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Cervical Cancer, Precancerous Condition

Intervention / Treatment
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* Genetic: microarray analysis
* Other: flow cytometry
* Procedure: biopsy
* Procedure: colposcopy


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Clinically suspicious malignant or premalignant cervical lesion Criteria Inclusion criteria: 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. Exclusion criteria: 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.

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Genetic: microarray analysis|nan|
|Other: flow cytometry|nan|
|Procedure: biopsy|nan|
|Procedure: colposcopy|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cervical cancer, cervical intraepithelial neoplasia grade 1, cervical intraepithelial neoplasia grade 2, cervical intraepithelial neoplasia grade 3