Cervical Disease
Conditions
Brief summary
1. Primary Objective: To compare the diagnostic accuracy of high-definition electronic magnifying endoscopy combined with image-enhanced technology versus colposcopy for cervical and vaginal lesions. 2. Secondary Objectives: To evaluate and compare the sensitivity, specificity, positive predictive value, and negative predictive value of the two examination methods, and to assess the differences between the two techniques in image characteristics, such as lesion border clarity and visualization of microvascular structures.
Interventions
DEVICEhigh-definition electronic magnifying endoscopy combined with image-enhanced technology
High-definition magnifying endoscopy (100-150×) enables clear visualization of microvascular and mucosal structures. In recent years, magnifying endoscopy combined with image-enhanced techniques (such as NBI/BLI/LCI) has established a well-developed vascular and epithelial interpretation system for the diagnosis of early esophageal squamous cell carcinoma. The cervix, vagina, and esophagus share the same stratified squamous epithelium, and the pathological evolution of precancerous lesions and early cancer exhibits similarities. Therefore, this technical framework may theoretically be transferable to the detection of lower genital tract lesions.
Sponsors
West China Second University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* ① Aged 18-65 years, with indications for colposcopy (HPV16/18 positive; HPV non-16/18 positive with LCT ≥ ASCUS; HPV negative with LCT ≥ LSIL; persistent HPV infection ≥ 1 year). * Voluntarily sign the informed consent form.
Exclusion criteria
* ① Women who are pregnant or breastfeeding. * Acute reproductive tract infection, severe coagulation disorders. ③ History of radiotherapy for malignant tumors, study participants with severe mental illness. * Underage women.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| diagnostic accuracy | At the time of issuing the histopathological report following biopsy, or at the time of follow-up (6-12 months) in cases where no biopsy was performed. |
| Sensitivity | At the time of issuing the histopathological report following biopsy, or at the time of follow-up (6-12 months) in cases where no biopsy was performed. |
| Specificity | At the time of issuing the histopathological report following biopsy, or at the time of follow-up (6-12 months) in cases where no biopsy was performed. |
| Positive Predictive Value (PPV) | At the time of issuing the histopathological report following biopsy, or at the time of follow-up (6-12 months) in cases where no biopsy was performed. |
| Negative Predictive Value (NPV) | At the time of issuing the histopathological report following biopsy, or at the time of follow-up (6-12 months) in cases where no biopsy was performed. |
| Area Under the Curve (AUC) | At the time of issuing the histopathological report following biopsy, or at the time of follow-up (6-12 months) in cases where no biopsy was performed. |
| Incidence of adverse events | At the time of issuing the histopathological report following biopsy, or at the time of follow-up (6-12 months) in cases where no biopsy was performed. |
Outcome results
None listed