Completed

Development of Antibody-Based Diagnostic Markers for Abnormal Cervical Cells

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What is being collected

Data Collection

+ other Data

+ other Data

Collected at a single point in time - Cross-sectional
OtherProcedure
Who is being recruted

Urogenital Diseases+10

+ Genital Diseases

+ Uterine Cervical Diseases

See all eligibility criteria
How is the trial designed

Cohort

Tracking disease incidence in order to identify risk factors and understand disease progression over time.
Observational
Study Start: August 1999
See protocol details

Summary

Principal SponsorNorthwestern University
Last updated: January 31, 2011
Sourced from a government-validated database.Claim as a partner

Study start date: August 1, 1999

Actual date on which the first participant was enrolled.

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.

NCT00004091
Principal SponsorNorthwestern University
Last updated: January 31, 2011
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

100 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Cohort

These studies follow a group of individuals with common characteristics (such as a condition or birth year) over a specific period to study health outcomes or exposures.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Female

Biological sex of participants that are eligible to enroll.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Urogenital DiseasesGenital DiseasesUterine Cervical DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsGenital Diseases, FemaleGenital Neoplasms, FemaleNeoplasmsNeoplasms by SiteUrogenital NeoplasmsUterine DiseasesUterine NeoplasmsFemale Urogenital DiseasesUterine Cervical Neoplasms

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

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Robert H. Lurie Comprehensive Cancer Center, Northwestern University

Chicago, United StatesOpen Robert H. Lurie Comprehensive Cancer Center, Northwestern University in Google Maps
CompletedOne Study Center