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NCT03179306 Clinical Trial

Cervix Image Sharing Protocol (CISP)

Cervical Cancer Clinical Trial

Official title:
Cervix Image Sharing Protocol (CISP)

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03179306
Other study ID # 999917098
Secondary ID 17-C-N098
Status Completed
Phase
First received
Last updated
Start date May 15, 2017
Est. completion date April 22, 2020

Study information
Verified date April 2020
Source National Institutes of Health Clinical Center (CC)
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The Clinical Epidemiology Unit in the Clinical Genetics Branch of the Division of Cancer Epidemiology, NCI has a strong interest in fostering cervical cancer prevention solutions for all kinds of settings, including lowresource ones that rely on development of robust, low-cost screening and triage tools. Therefore, to support development of algorithms for cervical image recognition software, NCI seeks to share digital cervical images and accompanying clinical data from our large epidemiological studies on HPV and cervical cancer screening with interested and qualified image analysis researchers. To accommodate the many researchers that are interested, we have created this standard protocol to describe a unified process for sharing deidentified cervical images and accompanying de-identified clinical data from the following NCI studies: Costa Rican Natural History Study of HPV and Cervical Neoplasia , ASCUS LSIL Triage Study-- ALTS , SUCCEED and Costa Rica Vaccine Trial .

Description:

The Clinical Epidemiology Unit in the Clinical Genetics Branch of the Division of Cancer Epidemiology, NCI has a strong interest in fostering cervical cancer prevention solutions for all kinds of settings, including lowresource ones that rely on development of robust, low-cost screening and triage tools. Therefore, to support development of algorithms for cervical image recognition software, NCI seeks to share digital cervical images and accompanying clinical data from our large epidemiological studies on HPV and cervical cancer

screening with interested and qualified image analysis researchers. To accommodate the many researchers that are interested, we have created this standard protocol to describe a unified process for sharing deidentified cervical images and accompanying de-identified clinical data from the following NCI studies: Costa Rican Natural History Study of HPV and Cervical Neoplasia , ASCUS LSIL Triage Study-- ALTS , SUCCEED and Costa Rica Vaccine Trial .

Recruitment information / eligibility
Status Completed
Enrollment 27084
Est. completion date April 22, 2020
Est. primary completion date April 22, 2020
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 100 Years
Eligibility - This protocol will include de-identified images and clinical data from NCI studies.

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
United States National Cancer Institute (NCI) Bethesda Maryland

Sponsors (1)
Lead Sponsor Collaborator
National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Cervical intraepithelial neoplasia grade 3 (CIN3) or worse. The identification of CIN3 or cancer in histopathology analyses of biopsy and cervical excisional specimens. Occurrence at enrollment or during follow-up.
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