A Multicenter Randomized Controlled Study of Photoelectric Detection in Cervical Cancer Screening

August 13, 2024 updated by: Lei Li

A Multicenter Randomized Controlled Study of Fluorescence Photoelectric Cervical Lesion Image Detector in Cervical Cancer Screening

The main purpose of this study is to verify the accuracy of the fluorescence photoelectric cervical lesion image detector relative to the pathological gold standard and the detection rate of CIN 2 +, as well as the significance of it as a shunt tool before colposcopy through a randomized controlled study.

The secondary objectives were to compare the relative pathological accuracy of the fluorescence photoelectric cervical lesion image detection results with the HPV detection results and cytological results, and to compare the lesion area displayed by the fluorescence photoelectric cervical lesion image detector with the lesion area that appeared after traditional colposcopy chemical staining.

In this study, 4200 subjects who have been evaluated and can be enrolled (these subjects have the indication of referral to colposcopy) will be included in the study, and they will be divided into two groups according to the principle of randomization. The histological results were obtained after routine colposcopy and biopsy. The experimental group first underwent colposcopy and biopsy after the judgment of the fluorescent photoelectric cervical lesion image detector to obtain histological results. Finally, the accuracy of the relative pathological results, the detection rate of CIN2 +, negative predictive value and positive predictive value of the two groups were compared.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

4200

Phase

  • Not Applicable

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

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

  • Primary Purpose: Screening
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group Accepting Photoelectric Detection
The subjects in this group need to undergo the detection of fluorescence photoelectric cervical lesion image detector before colposcopy, and then undergo routine colposcopy and biopsy after the detection.
Diagnostic test: Detection of Cervical Lesions by Fluorescence Photoelectric Image
Photoelectric detection was carried out on the subjects of the experimental group.
No Intervention: Routine colposcopy group
Subjects who entered this group underwent colposcopy and biopsy according to the routine gynecological examination procedure.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sensitivity and specificity of a fluorescence photoelectric image detector for cervical lesions.
Time Frame: Enrolled subjects receive histopathological results approximately 7 days after colposcopy.
Sensitivity and specificity of the fluorescence photoelectric detection technique relative to histopathological findings.
Enrolled subjects receive histopathological results approximately 7 days after colposcopy.
Detection rate of CIN2+ by fluorescence photoelectric cervical lesion image detector.
Time Frame: Enrolled subjects receive histopathological results approximately 7 days after colposcopy.
The sensitivity, specificity, CIN2+ detection rate, negative predictive value and positive predictive value were compared between the fluorescence photoelectric technology and HPV detection results and cytology results, and the consistency and coincidence between the fluorescence photoelectric technology and HPV detection results and cytology results were calculated.
Enrolled subjects receive histopathological results approximately 7 days after colposcopy.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The correlation between fluorescence photoelectric technology and HPV detection and cytology results.
Time Frame: Enrolled subjects receive histopathological results approximately 7 days after colposcopy.
The sensitivity, specificity, CIN2+ detection rate, negative predictive value and positive predictive value were compared with the results of HPV detection and cytology.
Enrolled subjects receive histopathological results approximately 7 days after colposcopy.

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)

August 1, 2024

Primary Completion (Estimated)

July 1, 2025

Study Completion (Estimated)

July 1, 2025

Study Registration Dates

First Submitted

July 1, 2024

First Submitted That Met QC Criteria

July 1, 2024

First Posted (Actual)

July 9, 2024

Study Record Updates

Last Update Posted (Actual)

August 15, 2024

Last Update Submitted That Met QC Criteria

August 13, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OITS2

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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