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Trial Title:
A Multicenter Randomized Controlled Study of Photoelectric Detection in Cervical Cancer Screening
NCT ID:
NCT06491888
Condition:
Uterine Cervical Cancer
Cervical Intraepithelial Neoplasia
High Grade Squamous Intraepithelial Lesions
Low Grade Squamous Intraepithelial Lesions
Conditions: Official terms:
Uterine Cervical Neoplasms
Uterine Cervical Dysplasia
Squamous Intraepithelial Lesions of the Cervix
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Screening
Masking:
None (Open Label)
Intervention:
Intervention type:
Diagnostic Test
Intervention name:
Detection of Cervical Lesions by Fluorescence Photoelectric Image
Description:
Photoelectric detection was carried out on the subjects of the experimental group.
Arm group label:
Group Accepting Photoelectric Detection
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.
Criteria for 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.
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.
Gender:
Female
Minimum age:
18 Years
Maximum age:
65 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Lei Li
Address:
City:
Beijing
Zip:
100730
Country:
China
Start date:
August 2024
Completion date:
July 2025
Lead sponsor:
Agency:
Lei Li
Agency class:
Other
Source:
Peking Union Medical College Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06491888
