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Development of Antibody-Based Diagnostic Markers for Abnormal Cervical Cells


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N/A
Not Enrolling
Female
Cervical Cancer

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Trial Information

Development of Antibody-Based Diagnostic Markers for Abnormal Cervical Cells


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.

Inclusion 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

Type of Study:

Observational

Study Design:

Observational Model: Cohort, Time Perspective: Cross-Sectional

Principal Investigator

Phillip Y. Roland, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Florida Gynecologic Oncology - Fort Myers

Authority:

United States: Federal Government

Study ID:

NU 99G3

NCT ID:

NCT00004091

Start Date:

August 1999

Completion Date:

February 2001

Related Keywords:

  • Cervical Cancer
  • cervical cancer
  • Uterine Cervical Neoplasms

Name

Location

Robert H. Lurie Comprehensive Cancer Center, Northwestern UniversityChicago, Illinois  60611