Status:
NOT_YET_RECRUITING
A Multicenter Randomized Controlled Study of Photoelectric Detection in Cervical Cancer Screening
Lead Sponsor:
Lei Li
Conditions:
Uterine Cervical Cancer
Cervical Intraepithelial Neoplasia
Eligibility:
FEMALE
18-65 years
Phase:
NA
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 +, ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2025
Estimated Enrollment :
4200 Patients enrolled
Trial Details
Trial ID
NCT06491888
Start Date
August 1 2024
End Date
July 1 2025
Last Update
August 15 2024
Active Locations (1)
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1
Lei Li
Beijing, Beijing Municipality, China, 100730