Detection of Biomarkers in Abnormal Cervical Cells in Women With Abnormal Pap Test Results
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|ClinicalTrials.gov Identifier: NCT00004091|
Recruitment Status : Completed
First Posted : March 1, 2004
Last Update Posted : January 31, 2011
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|
|Cervical Cancer||Other: Papanicolaou test Other: cytology specimen collection procedure Other: fluorescent antibody technique Procedure: colposcopic biopsy Procedure: study of high risk factors|
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 Type :||Observational|
|Estimated Enrollment :||100 participants|
|Official Title:||Development of Antibody-Based Diagnostic Markers for Abnormal Cervical Cells|
|Study Start Date :||August 1999|
|Actual Primary Completion Date :||February 2001|
|Actual Study Completion Date :||February 2001|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|