Spots Global Cancer Trial Database for Detection of Biomarkers in Abnormal Cervical Cells in Women With Abnormal Pap Test Results

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Trial Identification

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

Official Title: Development of Antibody-Based Diagnostic Markers for Abnormal Cervical Cells

Study ID: NCT00004091

Conditions

Cervical Cancer

Interventions

Papanicolaou test

cytology specimen collection procedure

fluorescent antibody technique

colposcopic biopsy

study of high risk factors

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.

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.