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

NCT ID: NCT00004091

Last Updated: 2011-01-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

1999-08-31

Study Completion Date

2001-02-28

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Cervical Cancer

Keywords

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cervical cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Interventions

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Papanicolaou test

Intervention Type OTHER

cytology specimen collection procedure

Intervention Type OTHER

fluorescent antibody technique

Intervention Type OTHER

colposcopic biopsy

Intervention Type PROCEDURE

study of high risk factors

Intervention Type PROCEDURE

Eligibility Criteria

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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
Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

Northwestern University

OTHER

Sponsor Role lead

Responsible Party

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Northwestern University

Principal Investigators

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Phillip Y. Roland, MD

Role: STUDY_CHAIR

Florida Gynecologic Oncology - Fort Myers

Locations

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Robert H. Lurie Comprehensive Cancer Center, Northwestern University

Chicago, Illinois, United States

Site Status

Countries

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United States

Other Identifiers

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NU-99G3

Identifier Type: -

Identifier Source: secondary_id

NCI-G99-1582

Identifier Type: -

Identifier Source: secondary_id

NU 99G3

Identifier Type: -

Identifier Source: org_study_id