A Multicenter Real-world Study of Screening of Cervical Cancer Based on Photoelectric Detection

Launched by LEI LI · Jun 25, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at a new way to detect cervical cancer using a special device that captures images of the cervix by detecting fluorescent light. The main goal is to see how accurate this new method is compared to traditional screening techniques like HPV testing and cervical cell samples (cytology). The study will involve around 20,000 women and will help understand which method works best for finding cervical lesions, which are changes in the cervix that could lead to cancer.

To participate in this study, women aged 18 to 65 who have clear screening results showing they might be at risk for cervical cancer are eligible. This includes those who have tested positive for certain types of HPV (the virus that can cause cervical cancer) or have had abnormal cell results. Participants can expect to undergo different screening tests and contribute to important research that could help improve cervical cancer prevention and treatment in China. It’s important to note that women with certain health conditions, like severe immune issues or active infections, will not be able to join the study.

Gender

FEMALE

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.