Detection of Biomarkers in Abnormal Cervical Cells in Women With Abnormal Pap Test Results
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.
Other: Papanicolaou test
Other: cytology specimen collection procedure
Other: fluorescent antibody technique
Procedure: colposcopic biopsy
Procedure: study of high risk factors
|Study Design:||Observational Model: Cohort
Time Perspective: Cross-Sectional
|Official Title:||Development of Antibody-Based Diagnostic Markers for Abnormal Cervical Cells|
|Study Start Date:||August 1999|
|Study Completion Date:||February 2001|
|Primary Completion Date:||February 2001 (Final data collection date for primary outcome measure)|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00004091
|United States, Illinois|
|Robert H. Lurie Comprehensive Cancer Center, Northwestern University|
|Chicago, Illinois, United States, 60611-3013|
|Study Chair:||Phillip Y. Roland, MD||Florida Gynecologic Oncology - Fort Myers|