Model Study on Cervical Cancer Screening Strategies and Risk Prediction

April 1, 2024 updated by: Fujian Maternity and Child Health Hospital
By collecting non-image medical data of women undergoing cervical screening in multiple centers in China, including age, HPV infection status, HPV infection type, TCT results, and colposcopy biopsy pathology results, a multi-source heterogeneous cervical lesion collaborative research big data platform was established. Based on artificial intelligence (AI) machine learning, cervical lesion screening features are refined, a multi-modal cervical cancer intelligent screening prediction and risk triage model is constructed, and its clinical application value is preliminarily explored.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

By collecting non-image medical data of women undergoing cervical screening in multiple centers in China, including age, HPV infection status, HPV infection type, TCT results, and colposcopy biopsy pathology results, a multi-source heterogeneous cervical lesion collaborative research big data platform was established. Based on artificial intelligence (AI) machine learning, cervical lesion screening features are refined, a multi-modal cervical cancer intelligent screening prediction and risk triage model is constructed, and its clinical application value is preliminarily explored. The effect of clinical application of the model was evaluated by internal data from Fujian Province and external data from several other regions in China.

Study Type

Observational

Enrollment (Estimated)

1500000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Fujian
      • Fuzhou, Fujian, China, 350001
        • Recruiting
        • Fujian Maternity and Child Health Hospital
        • Contact:
      • Ningde, Fujian, China
        • Recruiting
        • Ningde maternal and child health hospital
        • Contact:
          • Fengzhen Zhang
    • Guangdong
      • Foshan, Guangdong, China
        • Recruiting
        • Shunde Women's and Children's Hospital of Guangdong Medical University
        • Contact:
          • Shaomei Lin
      • Shenzhen, Guangdong, China
        • Recruiting
        • Shenzhen Maternal and Child Health Hospital
        • Contact:
          • Zheng Zheng
    • Hubei
      • Wuhan, Hubei, China
        • Recruiting
        • Hubei Maternal and Child Health Hospital
        • Contact:
          • Junbo Hu

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

For women aged 25-64 years who undergo cervical cancer screening, all women use HR-HPV testing as a primary screening strategy.

Description

Inclusion Criteria:

  • Age 25-64 years old;
  • There was no history of precancerous lesions or cervical cancer;
  • No previous cervical surgery or cervical removal;

Exclusion Criteria:

  • HPV test results are not available;
  • Pregnant or lactating women;
  • There is a serious immune system disease, and the disease is active;

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cervical histopathology
Time Frame: within 8 weeks，
Cervical histopathological diagnosis within 8 weeks
within 8 weeks，
colposcopy
Time Frame: Percentage of patients diagnosed with cervical intraepithelial neoplasia of grade 3 (CIN3) or worse by cervical histopathological measurements within 8 weeks
Colposcopists use colposcopic equipment to investigate the occurrence of cervical and vaginal lesions within 8 weeks
Percentage of patients diagnosed with cervical intraepithelial neoplasia of grade 3 (CIN3) or worse by cervical histopathological measurements within 8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fujian Maternity and Child Health Hospital

Investigators

  • Study Chair: Pengming Sun, Fujian Maternal and Child Health Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2023

Primary Completion (Estimated)

May 31, 2024

Study Completion (Estimated)

June 30, 2024

Study Registration Dates

First Submitted

December 15, 2023

First Submitted That Met QC Criteria

January 2, 2024

First Posted (Actual)

January 12, 2024

Study Record Updates

Last Update Posted (Actual)

April 2, 2024

Last Update Submitted That Met QC Criteria

April 1, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CSRM2304

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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