Identifying Biomarkers for Early Detection of Cancer in Patients With Cervical Dysplasia or Carcinoma in Situ of the Cervix
Primary Purpose
Cervical Cancer, Precancerous Condition
Status
Completed
Phase
Locations
Study Type
Observational
Intervention
Sponsored by
About this trial
This is an observational trial for Cervical Cancer focused on measuring stage 0 cervical cancer, cervical intraepithelial neoplasia grade 1, cervical intraepithelial neoplasia grade 2, cervical intraepithelial neoplasia grade 3
Eligibility 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
Sites / Locations
Outcomes
Primary Outcome Measures
Identify and catalogue genetic alterations and protein changes associated with developmental stages of cervical cancer
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
Completion of genome scans at high density and analysis of gene and protein expressions to identify recurrent genetic and protein changes in cancer
Changes clustered to specific chromosomal regions which harbor tumor suppressors or oncogenes
Secondary Outcome Measures
Full Information
NCT ID
NCT00601601
First Posted
January 25, 2008
Last Updated
March 7, 2012
Sponsor
British Columbia Cancer Agency
Collaborators
National Cancer Institute (NCI)
1. Study Identification
Unique Protocol Identification Number
NCT00601601
Brief Title
Identifying Biomarkers for Early Detection of Cancer in Patients With Cervical Dysplasia or Carcinoma in Situ of the Cervix
Official Title
Genomics Approach to Id Novel Targets & Markers for Early Detection And Intervention In Cancer (Cervical)
Study Type
Observational
2. Study Status
Record Verification Date
March 2012
Overall Recruitment Status
Completed
Study Start Date
December 2004 (undefined)
Primary Completion Date
April 2009 (Actual)
Study Completion Date
May 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
British Columbia Cancer Agency
Collaborators
National Cancer Institute (NCI)
4. Oversight
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervical Cancer, Precancerous Condition
Keywords
stage 0 cervical cancer, cervical intraepithelial neoplasia grade 1, cervical intraepithelial neoplasia grade 2, cervical intraepithelial neoplasia grade 3
7. Study Design
Enrollment
80 (Actual)
Primary Outcome Measure Information:
Title
Identify and catalogue genetic alterations and protein changes associated with developmental stages of cervical cancer
Time Frame
Done at the completion of the study.
Title
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.
Title
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.
Title
Changes clustered to specific chromosomal regions which harbor tumor suppressors or oncogenes
Time Frame
Done at the completion of the study.
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility 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
Study Population Description
All patients attending Vancouver General Hospital and referred to colposcopy for loop electrocautery excision procedure (LEEP).
Sampling Method
Probability Sample
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sylvia Lam
Organizational Affiliation
British Columbia Cancer Agency
Official's Role
Study Chair
12. IPD Sharing Statement
Learn more about this trial
Identifying Biomarkers for Early Detection of Cancer in Patients With Cervical Dysplasia or Carcinoma in Situ of the Cervix
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