Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A | Other | During the examination, traditional optical colposcopy (magnification: 7.5-15×) was first used for observation and image acquisition, followed by endoscopy (preset magnification: 90-120×). |
|
| Group B | Other | During the examination, endoscopy was performed first, followed by colposcopy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| high-definition electronic magnifying endoscopy combined with image-enhanced technology | Device | 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. |
| Measure | Description | 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. |
Not provided
Not provided
Inclusion Criteria:
①Aged 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).
Exclusion Criteria:
â‘ Women who are pregnant or breastfeeding.
Acute reproductive tract infection, severe coagulation disorders. â‘¢ History of radiotherapy for malignant tumors, study participants with severe mental illness.
Not provided
Not provided
Not provided
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 4, 2026 | Mar 27, 2026 |
Not provided
Not provided
Not provided
Not provided
Not provided
|
|
| Prot_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Mar 4, 2026 | Mar 27, 2026 | ICF_001.pdf |
| ID | Term |
|---|---|
| D002577 | Uterine Cervical Diseases |
| ID | Term |
|---|---|
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
Not provided
Not provided