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

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.

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

  • 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

Detailed Description

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.

Interventions

  • Genetic: microarray analysis
  • Other: flow cytometry
  • Procedure: biopsy
  • Procedure: colposcopy

Clinical Trial Outcome Measures

Primary 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

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.

Gender Eligibility: Female

Minimum Age: 19 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • British Columbia Cancer Agency
  • Collaborator
    • National Cancer Institute (NCI)
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Thomas G Ehlen, M.D., Principal Investigator, BC Cancer Agency, Vancouver General Hospital

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