A Multicenter Real-world Study of Screening of Cervical Cancer Based on Photoelectric Detection

June 30, 2024 updated by: Lei Li

The main purpose of this study is to explore the accuracy and clinical value of fluorescent photoelectric cervical lesion image detector as a screening and shunt tool for cervical lesions through a multi-center, large-sample real-world study with histopathology as the gold standard. The secondary purpose of the study was to verify the coincidence of the fluorescent photoelectric cervical lesion image detector with traditional colposcopic chemical staining.

This study is expected to include 20,000 participants with definite histological results, and compare the specificity and sensitivity, negative predictive value and positive predictive value of three cervical lesion screening methods, such as fluorescent photoelectric cervical lesion image detector, HPV nucleic acid detection and cytology detection. The advantages and disadvantages of fluorescent photoelectric cervical disease image detector, HPV nucleic acid detection and cytology examination were analyzed, and their application scenarios were provided to provide evidence-based medical support for the establishment of comprehensive prevention and treatment system of cervical cancer suitable for China's national conditions.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

20000

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 Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100730
        • Lei Li

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
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

This is a multicenter, parallel controlled, cross-sectional real-world study based on the population of a hospital gynecology clinic (gynecology clinic/colposcopy room).

Description

Inclusion Criteria:

  • 1. Age ≥ 18 years old, ≤ 65 years old, with a complete cervix without deformity.
  • 2. Have clear cervical cancer screening results, meet HPV16/18 (+) or high-risk HPV (+), and cervical cytology results ≥ ASC-US.
  • 3. Fully informed and agreed to participate in the study.
  • 4. No history of cervical cancer disease and cancer in other parts.

Exclusion Criteria:

  • 1. Cannot meet all Inclusion Criteria.
  • 2. There is clear immunosuppression, such as HIV infection or organ transplantation, etc., and the vagina or cervix is in the acute inflammation stage。
  • 3. There are serious bleeding diseases or photosensitive diseases such as abnormal coagulation.

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
The cervical lesion was detected by fluorescence photoelectricity in the enrolled patients
The enrolled patients were detected with fluorescence photoelectric cervical lesion image detector.
Diagnostic test: Detection of Cervical Lesions by Fluorescence Photoelectric Image
The enrolled patients underwent fluorescence photoelectric cervical lesion image detection, followed by colposcopy and biopsy to obtain histopathological results. The results of fluorescence photoelectric image detection were compared with histopathological results, and at the same time compared with HPV and TCT results at the time of enrollment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Accuracy of tissue lesion screening based on photoelectric detection
Time Frame: The data collection time for each subject is approximately 7 days, starting from the day of each subject's enrollment and ending when the pathology report of the cervical tissue biopsy under colposcopy is issued.
The sensitivity, specificity, positive predictive value and negative predictive value of fluorescence photoelectric cervix lesion image detector were calculated by using CIN 2 + as the gold standard determined by histopathology, and compared with those of HPV and TCT.
The data collection time for each subject is approximately 7 days, starting from the day of each subject's enrollment and ending when the pathology report of the cervical tissue biopsy under colposcopy is issued.

Collaborators and Investigators

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

Sponsor

Lei Li

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 (Estimated)

July 1, 2024

Primary Completion (Estimated)

July 1, 2026

Study Completion (Estimated)

July 1, 2026

Study Registration Dates

First Submitted

June 25, 2024

First Submitted That Met QC Criteria

June 25, 2024

First Posted (Actual)

July 1, 2024

Study Record Updates

Last Update Posted (Actual)

July 3, 2024

Last Update Submitted That Met QC Criteria

June 30, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • K5505

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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