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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
British Columbia Cancer Agency
About
Eligibility
Locations
Outcomes
Full info

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

19 Years - undefined (Adult, Older Adult)FemaleDoes not accept 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)

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

    First Posted
    January 25, 2008
    Last Updated
    March 7, 2012
    Sponsor
    British Columbia Cancer Agency
    Collaborators
    National Cancer Institute (NCI)
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    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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