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Internet-Based Cervical Cytology Screening Program


N/A
18 Years
64 Years
Open (Enrolling)
Female
Cervical Cancer

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Trial Information

Internet-Based Cervical Cytology Screening Program


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.


Inclusion Criteria:



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

Exclusion Criteria:

- Pregnant

- Prisoners

- Mentally unable to provide informed consent

Type of Study:

Observational

Study Design:

Observational Model: Case-Only, Time Perspective: Prospective

Principal Investigator

David C. Wilbur, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

MGH

Authority:

United States: Federal Government

Study ID:

2003P-001658

NCT ID:

NCT00658190

Start Date:

October 2003

Completion Date:

January 2013

Related Keywords:

  • Cervical Cancer
  • Cervical cancer, automation, Internet, telecytology
  • Uterine Cervical Neoplasms

Name

Location

Walter Reed Army Medical CenterWashington, District of Columbia  20307-5000
Massachusetts General HospitalBoston, Massachusetts  02114-2617