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

NCT ID: NCT06491888

Last Updated: 2024-08-15

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 4200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-08-31
• Study Completion Date: 2025-07-31

Brief Summary

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.

Conditions

Uterine Cervical Cancer; Cervical Intraepithelial Neoplasia; High Grade Squamous Intraepithelial Lesions; Low Grade Squamous Intraepithelial Lesions

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SCREENING
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Detection of Cervical Lesions by Fluorescence Photoelectric Image

Intervention Type: DIAGNOSTIC_TEST

Photoelectric detection was carried out on the subjects of the experimental group.

Routine colposcopy group

Subjects who entered this group underwent colposcopy and biopsy according to the routine gynecological examination procedure.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Detection of Cervical Lesions by Fluorescence Photoelectric Image

Photoelectric detection was carried out on the subjects of the experimental group.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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.

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Lei Li

OTHER

Sponsor Role: lead

Responsible Party

Lei Li

Chief physician

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Lei Li

Beijing, Beijing Municipality, China

Countries

China

Central Contacts

Lei Li, M.D.

Role: CONTACT

lileigh@163.com

+8613911988831

Other Identifiers

OITS2

Identifier Type: -

Identifier Source: org_study_id