Development of Antibody-Based Diagnostic Markers for Abnormal Cervical Cells
N/A
N/A
Female
Cervical Cancer
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 University | Chicago, Illinois 60611 |
