Cervix Image Sharing Protocol (CISP)

NCT ID: NCT03179306

Last Updated: 2020-04-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

27084 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-05-15

Study Completion Date

2020-04-22

Brief Summary

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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 .

Detailed Description

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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 .

Conditions

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Cervical Cancer Cervical Abnormalities

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Samples

de-identified images and clinical data from NCI studies.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* This protocol will include de-identified images and clinical data from NCI studies.
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Julia C Gage, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

National Cancer Institute (NCI)

Locations

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National Cancer Institute (NCI)

Bethesda, Maryland, United States

Site Status

Countries

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United States

Other Identifiers

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17-C-N098

Identifier Type: -

Identifier Source: secondary_id

999917098

Identifier Type: -

Identifier Source: org_study_id

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