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

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
Northwestern University
ClinicalTrials.gov Identifier:
NCT00004091
First received: December 10, 1999
Last updated: January 27, 2011
Last verified: January 2011
  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 Intervention
Cervical Cancer
Other: Papanicolaou test
Other: cytology specimen collection procedure
Other: fluorescent antibody technique
Procedure: colposcopic biopsy
Procedure: study of high risk factors

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Development of Antibody-Based Diagnostic Markers for Abnormal Cervical Cells

Resource links provided by NLM:


Further study details as provided by Northwestern University:

Estimated Enrollment: 100
Study Start Date: August 1999
Study Completion Date: February 2001
Primary Completion Date: February 2001 (Final data collection date for primary outcome measure)
Detailed Description:

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.

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

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients must have a diagnosis of an abnormal Pap test, performed as part of standard of care screening in the clinic. The patient's informed consent will be obtained during their initial interview with the clinic physician.

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

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

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: Not specified Endocrine therapy: Not specified Radiotherapy: No prior pelvic irradiation Surgery: No prior total hysterectomy

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00004091

Locations
United States, Illinois
Robert H. Lurie Comprehensive Cancer Center, Northwestern University
Chicago, Illinois, United States, 60611-3013
Sponsors and Collaborators
Northwestern University
Investigators
Study Chair: Phillip Y. Roland, MD Florida Gynecologic Oncology - Fort Myers
  More Information

Additional Information:
No publications provided

Responsible Party: John Lurain, MD, Northwestern University
ClinicalTrials.gov Identifier: NCT00004091     History of Changes
Other Study ID Numbers: NU 99G3, NU-99G3, NCI-G99-1582
Study First Received: December 10, 1999
Last Updated: January 27, 2011
Health Authority: United States: Federal Government

Keywords provided by Northwestern University:
cervical cancer

Additional relevant MeSH terms:
Uterine Cervical Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female
Antibodies
Immunoglobulins
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 22, 2014