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

Sponsor

British Columbia Cancer Agency (Other)

Overall Status

Terminated

CT.gov ID

NCT00629577

Collaborator

National Cancer Institute (NCI) (NIH)

Enrollment

Location

Duration (Months)

0.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

50 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

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

Study Start Date :

Sep 1, 2006

Actual Primary Completion Date :

Jun 1, 2010

Actual Study Completion Date :

Dec 1, 2011

Outcome Measures

Primary 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 []

Eligibility Criteria

Criteria

Ages Eligible for Study:

19 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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.