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.
Age range
18 Years – 65 Years
Sex
FEMALE
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The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
diagnostic accuracy
Timeframe: 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
Timeframe: 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
Timeframe: 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)
Timeframe: 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)
Timeframe: 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)
Timeframe: 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
Timeframe: 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.