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

NCT06491888 | Not Yet Recruiting

• 1 other identifier: OITS2
• Study Type: interventional
• Target: 4,200
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• Sensitivity and specificity of a fluorescence photoelectric image detector for cervical lesions.

  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.

  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 Outcomes (1)

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

  Enrolled subjects receive histopathological results approximately 7 days after colposcopy.

Study Arms (2)

Group Accepting Photoelectric Detection

EXPERIMENTAL

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

Routine colposcopy group

NO INTERVENTION

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

Interventions

Detection of Cervical Lesions by Fluorescence Photoelectric Image DIAGNOSTIC_TEST

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

Group Accepting Photoelectric Detection

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Age ≥ 18 years old, ≤ 65 years old, with a complete cervix without deformity.
• \. Have clear cervical cancer screening results, meet HPV16/18 (+) or high-risk HPV (+), and cervical cytology results ≥ ASC-US.
• \. Fully informed and agreed to participate in the study.
• \. No history of cervical cancer disease and cancer in other parts.

You may not qualify if:

• \. There is clear immunosuppression, such as HIV infection or organ transplantation, etc., and the vagina or cervix is in the acute inflammation stage。
• \. There are serious bleeding diseases or photosensitive diseases such as abnormal coagulation.

Sponsors & Collaborators

• Lei Li: lead

Study Sites (1)

Lei Li

Beijing, Beijing Municipality, 100730, China

Location

MeSH Terms

Conditions

Uterine Cervical Neoplasms; Uterine Cervical Dysplasia; Squamous Intraepithelial Lesions

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Precancerous Conditions; Morphological and Microscopic Findings; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Lei Li, M.D.

CONTACT

+8613911988831; lileigh@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Chief physician

Study Record Dates

• First Submitted: July 1, 2024
• First Posted: July 9, 2024
• Study Start: August 1, 2024
• Primary Completion: July 1, 2025
• Study Completion: July 1, 2025
• Last Updated: August 15, 2024

Record last verified: 2024-08

Locations

CN (1)