Cervix Image Sharing Protocol (CISP)

NCT03179306 | Completed

• 2 other identifiers: 99991709817-C-N098
• Study Type: observational
• Target: 27,084
• Locations: 1 country
• Sites: 1

Brief 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 .

Conditions

Cervical Cancer; Cervical Abnormalities

Keywords

Cervix; HPV; Imaging; Costa Rica

Outcome Measures

Primary Outcomes (1)

• 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.

Study Arms (1)

Samples

de-identified images and clinical data from NCI studies.

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

collection of images and data from other NCI studies

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (1)

National Cancer Institute (NCI)

Bethesda, Maryland, 20892, United States

Location

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Officials

• Julia C Gage, Ph.D.

  National Cancer Institute (NCI)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 6, 2017
• First Posted: June 7, 2017
• Study Start: May 15, 2017
• Primary Completion: April 22, 2020
• Study Completion: April 22, 2020
• Last Updated: April 28, 2020

Record last verified: 2020-04

Locations

US (1)