Clinical trial NCT00658190: Internet-Based Cervical Cytology Screening Program
Official title: Internet-Based Cervical Cytology Screening Program
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cervical Cancer
Keywords: Cervical cancer, automation, Internet, telecytology
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: Walter Reed Army Medical Center
name: U.S. Army Medical Research and Development Command
First posted: 2008-04-14
Enrollment: 175
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Females presenting to clinics at MGH or WRAMC for a Pap test

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.

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 criteria: Inclusion Criteria:

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

Exclusion Criteria:

* Pregnant
* Prisoners
* Mentally unable to provide informed consent

Primary outcomes:
measure: Cervical cytology abnormal cases
timeFrame: At enrollment
Secondary outcomes:
Other outcomes:
Locations:
city: Washington
country: United States
facility: Walter Reed Army Medical Center
state: District of Columbia
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: MGH
name: David C. Wilbur, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Walter Reed Army Medical Center
name: Barabara A Crothers, D.O
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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. doi: 10.1002/cncr.21098.