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Internet-Based Cervical Cytology Screening Program (IBCCSP)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00658190
First Posted: April 14, 2008
Last Update Posted: April 7, 2015
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.
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
April 9, 2008
April 14, 2008
April 7, 2015
October 2003
December 2012   (Final data collection date for primary outcome measure)
Cervical cytology abnormal cases [ Time Frame: At enrollment ]
Identification of abnormalities compared to the initial interpretation
Not Provided
Complete list of historical versions of study NCT00658190 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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Internet-Based Cervical Cytology Screening Program
Internet-Based Cervical Cytology Screening Program
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.
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.
Observational
Observational Model: Case-Only
Time Perspective: Prospective
Not Provided
Not Provided
Probability Sample
Females presenting to clinics at MGH or WRAMC for a Pap test
Cervical Cancer
Not Provided
1
Women obtaining routine Pap tests for cervical cancer screening
Eichhorn JH, Brauns TA, Gelfand JA, Crothers BA, Wilbur DC. A novel automated screening and interpretation process for cervical cytology using the internet transmission of low-resolution images: a feasibility study. Cancer. 2005 Aug 25;105(4):199-206.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
175
January 2013
December 2012   (Final data collection date for primary outcome measure)

Inclusion Criteria:

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

Exclusion Criteria:

  • Pregnant
  • Prisoners
  • Mentally unable to provide informed consent
Sexes Eligible for Study: Female
18 Years to 64 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00658190
2003P-001658
PRO33199 W81XWH-04-C-0083
No
Not Provided
Not Provided
David C. Wilbur, MD, Massachusetts General Hospital
Massachusetts General Hospital
  • Walter Reed Army Medical Center
  • U.S. Army Medical Research and Materiel Command
Principal Investigator: David C. Wilbur, MD MGH
Principal Investigator: Barabara A Crothers, D.O Walter Reed Army Medical Center
Massachusetts General Hospital
April 2012
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