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Detection of Biomarkers in Abnormal Cervical Cells in Women With Abnormal Pap Test Results

Sponsor
Northwestern University (Other)
Overall Status
Completed
CT.gov ID
NCT00004091
Collaborator
National Cancer Institute (NCI) (NIH)
100
Enrollment
1
Location
18.1
Duration (Months)
5.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

RATIONALE: Examining biomarkers in abnormal cervical cells may improve the ability to detect these cells and plan effective treatment.

PURPOSE: Diagnostic trial to detect specific biomarkers in abnormal cervical cells in women who have abnormal Pap test results.

Condition or Disease Intervention/Treatment Phase
  • Other: Papanicolaou test
  • Other: cytology specimen collection procedure
  • Other: fluorescent antibody technique
  • Procedure: colposcopic biopsy
  • Procedure: study of high risk factors

Detailed Description

OBJECTIVES: I. Compare the detection of transferrin receptor, epidermal growth factor receptor, and the MaTu-MN protein in exfoliated cervical epithelial cells from women with abnormal Pap test using fluorescent labeled antibody probe vs histology.

OUTLINE: Patients undergo a Pap test and a colposcopy. Cervical epithelial cells are collected from the most abnormal appearing lesion. Cells are examined for molecular markers using a fluorescent antibody test. The presence or absence of these markers is compared to results of the Pap test and the histology of the cells.

PROJECTED ACCRUAL: A total of 100 patients will be accrued for this study within 6 months.

Study Design

Study Type:
Observational
Anticipated Enrollment :
100 participants
Observational Model:
Cohort
Time Perspective:
Cross-Sectional
Official Title:
Development of Antibody-Based Diagnostic Markers for Abnormal Cervical Cells
Study Start Date :
Aug 1, 1999
Actual Primary Completion Date :
Feb 1, 2001
Actual Study Completion Date :
Feb 1, 2001

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No

    DISEASE CHARACTERISTICS: Diagnosis of abnormal Pap test, as indicated by one of the following: Atypical squamous cells of undetermined significance (ASCUS) Low grade squamous intraepithelial lesion (LGSIL) High grade squamous intraepithelial lesion (HGSIL) Visible lesion on cervix by colposcopy

    PATIENT CHARACTERISTICS: Age: Any age Performance status: ECOG 0-4 Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Other: Pregnant or nursing women allowed

    PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: Not specified Endocrine therapy: Not specified Radiotherapy: No prior pelvic irradiation Surgery: No prior total hysterectomy

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Robert H. Lurie Comprehensive Cancer Center, Northwestern University Chicago Illinois United States 60611-3013

    Sponsors and Collaborators

    • Northwestern University
    • National Cancer Institute (NCI)

    Investigators

    • Study Chair: Phillip Y. Roland, MD, Florida Gynecologic Oncology - Fort Myers

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00004091
    Other Study ID Numbers:
    • NU 99G3
    • NU-99G3
    • NCI-G99-1582
    First Posted:
    Mar 1, 2004
    Last Update Posted:
    Jan 31, 2011
    Last Verified:
    Jan 1, 2011
    Keywords provided by , ,
    cervical cancer
    Additional relevant MeSH terms:
    Uterine Cervical Neoplasms
    Antibodies

    Study Results

    No Results Posted as of Jan 31, 2011