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

Lei Li

Status: Not yet enrolling

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

Treatments: Diagnostic Test: Detection of Cervical Lesions by Fluorescence Photoelectric Image

Study type: Interventional

Funder types: Other

Identifiers

NCT06491888

OITS2

Details and patient eligibility

About

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.

Enrollment: 4,200 estimated patients

Sex: Female

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Screening

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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4,200 participants in 2 patient groups

Group Accepting Photoelectric Detection

Experimental group

Description:

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.

Treatment:

Diagnostic Test: Detection of Cervical Lesions by Fluorescence Photoelectric Image

Routine colposcopy group

No Intervention group

Description:

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