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

Completed

• Conditions: Cervical Cancer

• Registration Number: NCT00004091
• Lead Sponsor: Northwestern University

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.

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 Timeline

• Study Start: 1999-08
• Study First Submitted: 1999-12-10
• Primary Completion: 2001-02
• Study Completion: 2001-02
• Study First Submitted QC: 2004-02-27
• Study First Posted: 2004-03-01
• Status Verified: 2011-01
• Last Update Submitted: 2011-01-27
• Last Update Posted: 2011-01-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 100

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Trial Locations

Locations (1)

Robert H. Lurie Comprehensive Cancer Center, Northwestern University; 🇺🇸 Chicago, Illinois, United States