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

Phase 1

Terminated

• Conditions: Cervical Cancer; Precancerous Condition

• Registration Number: NCT00629577
• Lead Sponsor: British Columbia Cancer Agency

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.

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 Timeline

• Study Start: 2006-09
• Study First Submitted: 2008-03-05
• Study First Submitted QC: 2008-03-05
• Study First Posted: 2008-03-06
• Primary Completion: 2010-06
• Status Verified: 2010-11
• Study Completion: 2011-12
• Last Update Submitted: 2017-01-30
• Last Update Posted: 2017-02-01

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 50

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Classification of cervical cancer progression at a molecular level using gene expression profiling
Gene expression changes by microarray
Comparison of the expression profiles of clinical data to determine how accurately cell lines model the in vivo environment
Set of genes that classify the various grades of cervical cancer/dysplasia

Trial Locations

Locations (1)

BC Cancer Research Centre; 🇨🇦 Vancouver, British Columbia, Canada