Internet-Based Cervical Cytology Screening Program (IBCCSP)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2012 by Massachusetts General Hospital.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborators:
Walter Reed Army Medical Center
U.S. Army Medical Research and Materiel Command
Information provided by (Responsible Party):
David C. Wilbur, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT00658190
First received: April 9, 2008
Last updated: April 28, 2012
Last verified: April 2012
  Purpose

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
Cervical Cancer

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Internet-Based Cervical Cytology Screening Program

Resource links provided by NLM:


Further study details as provided by Massachusetts General Hospital:

Estimated Enrollment: 500
Study Start Date: October 2003
Estimated Study Completion Date: January 2013
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
1
Women obtaining routine Pap tests for cervical cancer screening

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.

  Eligibility

Ages Eligible for Study:   18 Years to 64 Years
Genders 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

Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00658190

Locations
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 Materiel Command
Investigators
Principal Investigator: David C. Wilbur, MD MGH
Principal Investigator: Barabara A Crothers, D.O Walter Reed Army Medical Center
  More Information

Publications:
Responsible Party: David C. Wilbur, MD, Pathologist, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00658190     History of Changes
Other Study ID Numbers: 2003P-001658, PRO33199 W81XWH-04-C-0083
Study First Received: April 9, 2008
Last Updated: April 28, 2012
Health Authority: United States: Federal Government

Keywords provided by Massachusetts General Hospital:
Cervical cancer, automation, Internet, telecytology

Additional relevant MeSH terms:
Uterine Cervical Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female

ClinicalTrials.gov processed this record on April 21, 2014