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| ID | Type | Description | Link |
|---|---|---|---|
| PRO33199 W81XWH-04-C-0083 |
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| Name | Class |
|---|---|
| Walter Reed Army Medical Center | FED |
| U.S. Army Medical Research and Development Command | FED |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Women obtaining routine Pap tests for cervical cancer screening |
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| Measure | Description | Time Frame |
|---|---|---|
| Cervical cytology abnormal cases | Identification of abnormalities compared to the initial interpretation | At enrollment |
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Inclusion Criteria:
Exclusion Criteria:
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Females presenting to clinics at MGH or WRAMC for a Pap test
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| Name | Affiliation | Role |
|---|---|---|
| David C. Wilbur, MD | MGH | Principal Investigator |
| Barabara A Crothers, D.O | Walter Reed Army Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Walter Reed Army Medical Center | Washington D.C. | District of Columbia | 20001 | United States | ||
| Massachusetts General Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15937917 | Background | 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. |
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| ID | Term |
|---|---|
| D002583 | Uterine Cervical Neoplasms |
| ID | Term |
|---|---|
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
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| Boston |
| Massachusetts |
| 02114 |
| United States |
| D009369 |
| Neoplasms |
| D002577 | Uterine Cervical Diseases |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |