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
screening for cervical cancer Cervical Cancer

Further Study 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.

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

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

Study chairs or principal investigators

Phillip Y. Roland,  Study Chair,  Robert H. Lurie Cancer Center   

Study ID Numbers:  CDR0000067304; NU-99G3; NCI-G99-1582
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