Detection of Biomarkers in Abnormal Cervical Cells in Women With Abnormal Pap Test Results - Article
Clinical Trial: Detection of Biomarkers in Abnormal Cervical Cells in Women With Abnormal Pap Test Results
This study is no longer recruiting patients.
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.
|screening for cervical cancer |
MedlinePlus related topics: Cervical Cancer
Study Type: Observational
Study Design: Screening
Study start: August 1999
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.
PROTOCOL 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.
PROTOCOL ENTRY CRITERIA:
- 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
- Biologic therapy: Not specified
- Chemotherapy: Not specified
- Endocrine therapy: Not specified
- Radiotherapy: No prior pelvic irradiation
- Surgery: No prior total hysterectomy
- 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
Robert H. Lurie Comprehensive Cancer Center, Northwestern University, Chicago, Illinois, 60611-3013, United States
Phillip Y. Roland, Study Chair, Robert H. Lurie Cancer Center
Record last reviewed: February 2004
Last Updated: October 13, 2004
Record first received: December 10, 1999
ClinicalTrials.gov Identifier: NCT00004091
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08
Cache Date: April 9, 2005