Identifying Biomarkers for Early Detection of Cancer in Patients With Cervical Dysplasia or Carcinoma in Situ of the Cervix

Completed

• Conditions: Cervical Cancer; Precancerous Condition

• Registration Number: NCT00601601
• Lead Sponsor: British Columbia Cancer Agency

Brief Summary

RATIONALE: Studying the genes expressed in samples of tissue from patients with abnormal cells may help doctors identify biomarkers related to cancer.

PURPOSE: This clinical trial is identifying biomarkers for early detection of cancer in women with cervical dysplasia or carcinoma in situ of the cervix.

Detailed Description

OBJECTIVES:

Primary

* To identify and catalogue genetic alterations and protein changes associated with developmental stages of cervical cancer.

* To identify a ranked list of candidate genes that drive the transformation of premalignant lesions to tumors for further study and validation as molecular targets for novel early detection and treatment design.

Secondary

* To complete genome scans at high density and analysis of gene and protein expression to identify recurrent genetic and protein changes in cancer.

* To confirm changes clustered to specific chromosomal regions which harbor tumor suppressors or oncogenes.

OUTLINE: Patients undergo biopsy of cervical tissue followed by loop electrocautery excision procedure (LEEP) (removing all of the tissue surrounding and under the area biopsied). RNA, DNA, and protein is extracted from the cells to provide material for the construction of libraries for Serial Analysis of Gene Expression (SAGE analysis); for hybridization against Bacterial Artificial Chromosome Comparative Genome Hybridization arrays (BAC CGH arrays); and for analysis using protein chip arrays and proteomics. Resulting data from coded samples provide gene expression and protein profiles. The coded molecular datasets are linked, analyzed, and compared using a variety of statistical software to identify putative genes, gene alterations, and proteins of interest. Some samples may be banked for future studies.

Study Timeline

• Study Start: 2004-12
• Study First Submitted: 2008-01-25
• Study First Submitted QC: 2008-01-25
• Study First Posted: 2008-01-28
• Primary Completion: 2009-04
• Study Completion: 2011-05
• Status Verified: 2012-03
• Last Update Submitted: 2012-03-07
• Last Update Posted: 2012-03-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 80

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Identify and catalogue genetic alterations and protein changes associated with developmental stages of cervical cancer	Done at the completion of the study.
Identify a ranked list of candidate genes that drive the transformation of premalignant lesions to tumors for further study and validation as molecular targets for novel early detection and treatment design	Done at the completion of the study.
Completion of genome scans at high density and analysis of gene and protein expressions to identify recurrent genetic and protein changes in cancer	Done at the completion of the study.
Changes clustered to specific chromosomal regions which harbor tumor suppressors or oncogenes	Done at the completion of the study.