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



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

For Condition: screening for cervical cancer,Cervical Cancer
Status: No longer recruiting
Sponsor(s): National Cancer Institute (NCI) , Robert H. Lurie Cancer Center
Synopsis: 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.
Details: 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.
Eligibility:
Study Type:
  Observational, Screening
Minimum Age/Maximum Age: /
Genders: 
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - 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 --Prior/Concurrent Therapy-- - Biologic therapy: Not specified - Chemotherapy: Not specified - Endocrine therapy: Not specified - Radiotherapy: No prior pelvic irradiation - Surgery: No prior total hysterectomy --Patient Characteristics-- - 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
Total Enrollment: 

Location and Contact Information:

Overall Study Official:
PhillipRoland,  Study Chair,  Robert H. Lurie Cancer Center

Robert H. Lurie Comprehensive Cancer Center, Northwestern University
Chicago,  Illinois,  60611-3013
United States
 


Additional Information:
Study ID Numbers:
  CDR0000067304;  NU-99G3,NCI-G99-1582
Study Start Date: August 1999
Record last reviewed: February 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00004091

Other Screening For Cervical Cancer Studies:
1. Detection of Biomarkers in Abnormal Cervical Cells in Women With Abnormal Pap Test Results

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