Clinical trial NCT06481930: A Multicenter Real-world Study of Screening of Cervical Cancer Based on Photoelectric Detection
Official title: A Multicenter Real-world Study of Screening of Cervical Cancer Based on Photoelectric Detection
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Uterine Cervical Cancer
High Grade Squamous Intraepithelial Lesions
Low Grade Squamous Intraepithelial Lesions
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2024-07-01
Enrollment: 20000
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CROSSOVER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This is a multicenter, parallel controlled, cross-sectional real-world study based on the population of a hospital gynecology clinic (gynecology clinic/colposcopy room).

Brief summary: The main purpose of this study is to explore the accuracy and clinical value of fluorescent photoelectric cervical lesion image detector as a screening and shunt tool for cervical lesions through a multi-center, large-sample real-world study with histopathology as the gold standard. The secondary purpose of the study was to verify the coincidence of the fluorescent photoelectric cervical lesion image detector with traditional colposcopic chemical staining.

This study is expected to include 20,000 participants with definite histological results, and compare the specificity and sensitivity, negative predictive value and positive predictive value of three cervical lesion screening methods, such as fluorescent photoelectric cervical lesion image detector, HPV nucleic acid detection and cytology detection. The advantages and disadvantages of fluorescent photoelectric cervical disease image detector, HPV nucleic acid detection and cytology examination were analyzed, and their application scenarios were provided to provide evidence-based medical support for the establishment of comprehensive prevention and treatment system of cervical cancer suitable for China's national conditions.


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.

Primary outcomes:
measure: Accuracy of tissue lesion screening based on photoelectric detection
timeFrame: The data collection time for each subject is approximately 7 days, starting from the day of each subject's enrollment and ending when the pathology report of the cervical tissue biopsy under colposcopy is issued.
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Lei Li
state: Beijing
Study officials:
References: