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IBCCSP: Internet-Based Cervical Cytology Screening Program

Sponsor
Massachusetts General Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT00658190
Collaborator
Walter Reed Army Medical Center (U.S. Fed), U.S. Army Medical Research and Development Command (U.S. Fed)
175
Enrollment
2
Locations
111
Duration (Months)
87.5
Patients Per Site
0.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to assess whether a system that couples automated screening of Pap Tests with transmission of machine selected digital images, and review by cytologists at a remote location, performs to a clinically effective standard of accuracy.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    This clinical study uses the automated screening capabilities of the FocalPoint Primary Screening System (BD) for gynecologic cytology specimens (Pap tests) to allow for automated field of view (FOV) selection, digital image capture, and subsequent Internet-based transmission to a custom designed computer-based image reading station. The system utilizes liquid-based cytology preparations (ThinPrep, SurePath). In such a system, no skilled cytology human resources are necessary at the scanning site, and all expertise can be centralized. Pilot studies showed that the task was feasible to a clinically relevant standard of care. Phase 1 trials on preselected and seeded specimens confirmed this clinical standard. The phase 2 trials extend the concept to a prospectively enrolled population of patients from 2 sites (Walter Reed, Mass General) thereby testing the concept in a population of normal disease prevalence. The final phase 3 will be a larger study with intended use design, siting a screening device at the 121st Army Hospital in Korea and interpreting the specimen images in the US. In addition to the reading of the specimens, the system is designed to give immediate "loop closing" results back to each specimen's originating point immediate upon completion of the test.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    175 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Prospective
    Official Title:
    Internet-Based Cervical Cytology Screening Program
    Study Start Date :
    Oct 1, 2003
    Actual Primary Completion Date :
    Dec 1, 2012
    Actual Study Completion Date :
    Jan 1, 2013

    Arms and Interventions

    Arm Intervention/Treatment
    1

    Women obtaining routine Pap tests for cervical cancer screening

    Outcome Measures

    Primary Outcome Measures

    1. Cervical cytology abnormal cases [At enrollment]

      Identification of abnormalities compared to the initial interpretation

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 64 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • Female presenting to clinic for a Pap test for any reason
    Exclusion Criteria:

    • Pregnant

    • Prisoners

    • Mentally unable to provide informed consent

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Walter Reed Army Medical Center Washington District of Columbia United States 20001
    2 Massachusetts General Hospital Boston Massachusetts United States 02114

    Sponsors and Collaborators

    • Massachusetts General Hospital
    • Walter Reed Army Medical Center
    • U.S. Army Medical Research and Development Command

    Investigators

    • Principal Investigator: David C. Wilbur, MD, MGH
    • Principal Investigator: Barabara A Crothers, D.O, Walter Reed Army Medical Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    David C. Wilbur, MD, Pathologist, Massachusetts General Hospital
    ClinicalTrials.gov Identifier:
    NCT00658190
    Other Study ID Numbers:
    • 2003P-001658
    • PRO33199 W81XWH-04-C-0083
    First Posted:
    Apr 14, 2008
    Last Update Posted:
    Apr 7, 2015
    Last Verified:
    Apr 1, 2012
    Keywords provided by David C. Wilbur, MD, Pathologist, Massachusetts General Hospital
    Cervical cancer, automation, Internet, telecytology
    Additional relevant MeSH terms:
    Uterine Cervical Neoplasms

    Study Results

    No Results Posted as of Apr 7, 2015