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

NCT06491888 — Not applicable, Unknown, 4200 participants, Lei Li

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

Registry	NCT06491888
Status	Unknown
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: none, screening
Enrollment	4200 (Estimated)
Sponsor	Lei Li (Other)
Conditions	Uterine Cervical Cancer, Cervical Intraepithelial Neoplasia, High Grade Squamous Intraepithelial Lesions, Low Grade Squamous Intraepithelial Lesions
Interventions	Detection of Cervical Lesions by Fluorescence Photoelectric Image (Diagnostic test)
Dates	start 2024-08-01 (estimated), primary completion 2025-07-01 (estimated), completion 2025-07-01 (estimated), first posted 2024-07-09, last updated 2024-08-15
Locations	1 site in China

-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.

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+Arms and interventions

Arm	Type	Interventions	Description
Group Accepting Photoelectric Detection	Experimental	Diagnostic Test: Detection of Cervical Lesions by Fluorescence Photoelectric Image	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.
Routine colposcopy group	No intervention		Subjects who entered this group underwent colposcopy and biopsy according to the routine gynecological examination procedure.

Detection of Cervical Lesions by Fluorescence Photoelectric Image (Diagnostic test): Photoelectric detection was carried out on the subjects of the experimental group.

+Outcome measures

Primary outcomes

Sensitivity and specificity of a fluorescence photoelectric image detector for cervical lesions. [Enrolled subjects receive histopathological results approximately 7 days after colposcopy.]: Sensitivity and specificity of the fluorescence photoelectric detection technique relative to histopathological findings.
Detection rate of CIN2+ by fluorescence photoelectric cervical lesion image detector. [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.

Secondary outcomes

The correlation between fluorescence photoelectric technology and HPV detection and cytology results. [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.

+Eligibility

Sex: Female, ages: 18 Years to 65 Years

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.

+Locations (1)

Facility	City	Country	Status
Lei Li	Beijing, Beijing Municipality	China