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Clinical Trials/NCT00601601
NCT00601601
Completed
Not Applicable

Genomics Approach to Id Novel Targets & Markers for Early Detection And Intervention In Cancer (Cervical)

British Columbia Cancer Agency0 sites80 target enrollmentDecember 2004

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cervical Cancer
Sponsor
British Columbia Cancer Agency
Enrollment
80
Primary Endpoint
Identify and catalogue genetic alterations and protein changes associated with developmental stages of cervical cancer
Status
Completed
Last Updated
14 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
December 2004
End Date
May 2011
Last Updated
14 years ago
Study Type
Observational
Sex
Female

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Identify and catalogue genetic alterations and protein changes associated with developmental stages of cervical cancer

Time Frame: 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

Time Frame: 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

Time Frame: Done at the completion of the study.

Changes clustered to specific chromosomal regions which harbor tumor suppressors or oncogenes

Time Frame: Done at the completion of the study.

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