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

Cervical Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00601601
• Other study ID #: CDR0000581302
• Secondary ID: R01CA103830BCCR-
• Status: Completed
• Phase: N/A
• First received: January 25, 2008
• Last updated: March 7, 2012
• Start date: December 2004
• Est. completion date: May 2011

Study information

• Verified date: March 2012
• Source: British Columbia Cancer Agency
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: May 2011
• Est. primary completion date: April 2009
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 19 Years and older

Eligibility

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

Study Design

N/A

Related Conditions & MeSH terms

• Cervical Cancer
• Precancerous Condition
• Precancerous Conditions
• Uterine Cervical Neoplasms

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
British Columbia Cancer Agency	National Cancer Institute (NCI)

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Identify and catalogue genetic alterations and protein changes associated with developmental stages of cervical cancer		Done at the completion of the study.	No
Primary	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.	No
Primary	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.	No
Primary	Changes clustered to specific chromosomal regions which harbor tumor suppressors or oncogenes		Done at the completion of the study.	No