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

NCT ID: NCT00601601

Last Updated: 2012-03-09

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 80 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2004-12-31
• Study Completion Date: 2011-05-31

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.

Conditions

Cervical Cancer; Precancerous Condition

Eligibility Criteria

Inclusion Criteria

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)

PATIENT CHARACTERISTICS:

• Not pregnant
• No lack of informed consent due to language difficulty, physical and mental condition

PRIOR CONCURRENT THERAPY:

• No prior operation for removal of the cervix
• Concurrent therapy allowed

• Minimum Eligible Age: 19 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

British Columbia Cancer Agency

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sylvia Lam

Role: STUDY_CHAIR

British Columbia Cancer Agency

Other Identifiers

R01CA103830

Identifier Type: NIH

Identifier Source: secondary_id

View Link

BCCR-H04-60112

Identifier Type: -

Identifier Source: secondary_id

BCCR-RO4-0112

Identifier Type: -

Identifier Source: secondary_id

CDR0000581302

Identifier Type: -

Identifier Source: org_study_id