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

Sponsor

British Columbia Cancer Agency (Other)

Overall Status

Completed

CT.gov ID

NCT00601601

Collaborator

National Cancer Institute (NCI) (NIH)

Enrollment

76.9

Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cervical Cancer Precancerous Condition

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 Design

Study Type:

Observational

Actual Enrollment :

80 participants

Official Title:

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

Study Start Date :

Dec 1, 2004

Actual Primary Completion Date :

Apr 1, 2009

Actual Study Completion Date :

May 1, 2011

Outcome Measures

Primary Outcome Measures

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.]

Eligibility Criteria

Criteria

Ages Eligible for Study:

19 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

DISEASE CHARACTERISTICS:

Histologically or cytologically confirmed premalignant lesion, dysplasia, or carcinoma in situ of the cervix
Clinically documented disease
Attending Vancouver General Hospital and referred to colposcopy for loop electrocautery excision procedure (LEEP)