Internet-Based Cervical Cytology Screening Program

Cervical Cancer Clinical Trial

— IBCCSP  

Official title:

Internet-Based Cervical Cytology Screening Program

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00658190
• Other study ID #: 2003P-001658
• Secondary ID: PRO33199 W81XWH-
• Status: Completed
• Phase: N/A
• First received: April 9, 2008
• Last updated: April 6, 2015
• Start date: October 2003
• Est. completion date: January 2013

Study information

• Verified date: April 2012
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 175
• Est. completion date: January 2013
• Est. primary completion date: December 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 64 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Pregnant

• Prisoners

• Mentally unable to provide informed consent

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Cervical Cancer
• Uterine Cervical Neoplasms

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	Walter Reed Army Medical Center	Washington	District of Columbia

Sponsors (3)

Lead Sponsor	Collaborator
Massachusetts General Hospital	U.S. Army Medical Research and Materiel Command, Walter Reed Army Medical Center

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cervical cytology abnormal cases	Identification of abnormalities compared to the initial interpretation	At enrollment	Yes