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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. Healing Touch and Immunity in Advanced Cervical Cancer Patients

2. Peripheral Stem Cell Transplantation, White Blood Cell Infusions, Chemotherapy, and Radiation Therapy in Treating Patients With Recurrent Metastatic Cervical or Vaginal Cancer

3. Epoetin beta in Treating Anemia in Patients With Cervical Cancer

4. Tretinoin in Preventing Cancer of the Cervix in Patients With Cervical Neoplasia

5. Carotenoid Rich Diet in Treating Cervical Dysplasia

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

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