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

Launched by LEI LI · Jul 1, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new device that uses light to help detect cervical cancer and other cervical problems more accurately during screening. The goal is to see how well this light-based detector compares to traditional methods, such as biopsies and lab tests, in identifying significant issues like high-grade lesions. Researchers plan to enroll 4,200 women aged 18 to 65 who have already received abnormal cervical screening results, indicating they need further examination. Participants will be randomly assigned to either have their screening assessed with this new device first or to follow the standard procedure.

Women who join the study can expect to undergo a standard colposcopy, which is a closer examination of the cervix, along with a biopsy if needed. To participate, they must have clear results from previous cervical cancer screenings and cannot have a history of cervical cancer or be currently undergoing treatments that could affect their immune system. This trial aims to improve the way cervical cancer is detected, potentially making screening safer and more effective for future patients.

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.