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

Phase 1TerminatedNCT00629577

British Columbia Cancer Agency50 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Cervical Cancer Precancerous Condition

Interventions

microarray analysisGENETIC

flow cytometryOTHER

biopsyPROCEDURE

colposcopyPROCEDURE

Eligibility

Sex: FEMALEMin age: 19 Years

Medical Language ↔ Plain English

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.

Locations (1)

BC Cancer Research Centre

Vancouver, British Columbia, Canada

Outcomes

Primary Outcomes

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

Data from ClinicalTrials.gov

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