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

This study is no longer recruiting patients.

Sponsors and Collaborators: National Cancer Institute (NCI)
Robert H. Lurie Cancer Center
Information provided by: National Cancer Institute (NCI)

Purpose

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

MedlinePlus related topics:  Cervical Cancer

Study Type: Observational
Study Design: Screening

Official Title: Detection of Diagnostic Biomarkers in Abnormal Cervical Cells in Women with Abnormal Pap Test

Further Study Details: 

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.

Eligibility

Criteria

PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

--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

Location Information


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   

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database

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


Source: ClinicalTrials.gov
Cache Date: April 9, 2005

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