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Internet-Based Cervical Cytology Screening Program (IBCCSP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00658190
Recruitment Status : Completed
First Posted : April 14, 2008
Last Update Posted : April 7, 2015
Walter Reed Army Medical Center
U.S. Army Medical Research and Development Command
Information provided by (Responsible Party):
David C. Wilbur, MD, Massachusetts General Hospital

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
Cervical Cancer

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.

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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 : October 2003
Actual Primary Completion Date : December 2012
Actual Study Completion Date : January 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cervical Cancer

Women obtaining routine Pap tests for cervical cancer screening

Primary Outcome Measures :
  1. Cervical cytology abnormal cases [ Time Frame: At enrollment ]
    Identification of abnormalities compared to the initial interpretation

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Females presenting to clinics at MGH or WRAMC for a Pap test

Inclusion Criteria:

  • Female presenting to clinic for a Pap test for any reason

Exclusion Criteria:

  • Pregnant
  • Prisoners
  • Mentally unable to provide informed consent

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00658190

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United States, District of Columbia
Walter Reed Army Medical Center
Washington, District of Columbia, United States, 20001
United States, Massachusetts
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
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Principal Investigator: David C. Wilbur, MD MGH
Principal Investigator: Barabara A Crothers, D.O Walter Reed Army Medical Center

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Responsible Party: David C. Wilbur, MD, Pathologist, Massachusetts General Hospital Identifier: NCT00658190    
Other Study ID Numbers: 2003P-001658
PRO33199 W81XWH-04-C-0083
First Posted: April 14, 2008    Key Record Dates
Last Update Posted: April 7, 2015
Last Verified: April 2012
Keywords provided by David C. Wilbur, MD, Massachusetts General Hospital:
Cervical cancer, automation, Internet, telecytology
Additional relevant MeSH terms:
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Uterine Cervical Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female