Study on Novel Strategies for Cervical Cancer Screening Using Photoelectric Detection and Epigenetic Procotol (CC-AZ)

March 4, 2025 updated by: Peking Union Medical College Hospital

Study on Novel Strategies for Cervical Cancer Screening Using Photoelectric Detection Combined with Epigenetic Procotol

A national multicenter, open randomized controlled study was conducted. It is planned to invite 30 multi-center units across the country to compete for enrollment, and each multi-center will enroll 140 patients meeting colposcopic indications (70 in the conventional group and 70 in the experimental group), totaling 4200 patients. Enrolled subjects were randomly divided into two groups. Methylation test + colposcopic biopsy was performed in the conventional group, and clinical follow-up was performed according to the methylation results; in the experimental group, methylation test + colposcopic biopsy +OITS was performed, and clinical follow-up was performed according to the methylation results and OITS results. To verify the effectiveness of methylation tests and OITS in screening for CIN2+, whether they can reduce missed diagnosis of CIN2+, whether they can flag excessive colposcopic procedures, and the value of clinical follow-up for cervical lesions.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

4200

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

Probability Sample

Study Population

There are 30 multi-center units in the country, and each center competes to enter the group. The accuracy of OITS early data was 75%, the sensitivity was 82%, and the specificity was 63%. According to 20% shedding, possible causes of shedding: error caused by severe inflammatory patients, error caused by improper operation or subjects unwilling to cooperate with follow-up. The optimal efficacy test was performed with the rate of 0.75 in the experimental group and 0.5 in the control group, and the optimal efficacy threshold was 0.1(control-experimental group), bilateral alpha was 0.05, beta was 0.2, and the sample size ratio of the two groups was 1(experimental group: Control group), each single center needs to collect 58 cases in the experimental group and 58 cases in the control group. Considering 20% shedding, the sample size of each single center is at least 70 cases in the experimental group and 70 cases in the control group, and a total of 4200 cases of all centers.

Description

Inclusion Criteria:

  1. Women between the ages of 18 and 65 who have already had sex life
  2. HPV16, 18 positive or high-risk HPV infection with cytology ≧ASC-US
  3. No history of cervical cancer and cervical physical therapy, a complete cervix
  4. No menstrual period, no sexual activity and vaginal medication within 48 hours
  5. The vagina or cervix is not in a stage of acute inflammation
  6. Willing to participate in the study with full informed consent

Exclusion Criteria:

  1. Cervical dysplasia (congenital malformation or double uterus, etc.)
  2. History of cervical treatment (coning, ablation, or photodynamic therapy)
  3. There are definite immunosuppression conditions, such as HIV infection or organ transplantation
  4. Patients with severe bleeding diseases such as coagulation abnormalities or photosensitive diseases (such as porphyria, lupus erythematosus, etc.)
  5. A history of radiation or chemotherapy (e.g., pelvic radiation therapy) with cancer at other sites
  6. The patient is in pregnancy or puerperium
  7. The other conditions of this study were not considered appropriate by the researchers

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
control group
Methylation test and colposcopic biopsy, and clinical follow-up based on methylation results
OITS group
The experimental group underwent methylation test and colposcopic biopsy and OITS, and clinical follow-up was conducted according to methylation results and OITS results
Diagnostic test: photoelectric detection
Methylation test and colposcopic biopsy was performed in the conventional group, and clinical follow-up was performed according to the methylation results; in the experimental group, methylation test and colposcopic biopsy and OITS was performed, and clinical follow-up was performed according to the methylation results and OITS results.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sensitivity and specificity of a photoelectric image detector for cervical lesions
Time Frame: Enrolled subjects receive histopathological results approximately 7 days after colposcopy
Sensitivity and specificity of the photoelectric detection technique relative to histopathological findings.
Enrolled subjects receive histopathological results approximately 7 days after colposcopy

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Detection rate of CIN2+ by 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 with the results of Methylaiton, colpscopy, 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

Peking Union Medical College 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 (Estimated)

March 15, 2025

Primary Completion (Estimated)

March 15, 2027

Study Completion (Estimated)

March 15, 2028

Study Registration Dates

First Submitted

March 4, 2025

First Submitted That Met QC Criteria

March 4, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 4, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CCAZ

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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