Quality Control of Colposcopy Application

Completed

• Conditions: Cervical Cancers; Cervical Intraepithelial Neoplasia (CIN)

• Registration Number: NCT06823817
• Lead Sponsor: Peking Union Medical College Hospital

Brief Summary

Colposcopy has become an important link and tool in the prevention and treatment of cervical cancer. The quality and pathological assessment of colposcopy is a key point in follow-up and treatment.The main purpose of this study was to analyze the correlation between colposcopy indications and pathological findings.

Detailed Description

1. inclusion/exclusion criteria inclusion：(1) at least 18 years of age; (2) Complete colposcopy report; (3) Clear pathological diagnosis was reported after colposcopic biopsy.

exclusion：Not all of the above criteria are met

2. study purpose Main purpose

1）analyze the correlation between colposcopy indications and pathological findings Secondary purpose

1. Influence of colposcopic transformation area type on pathological evaluation

2. Colposcopic follow-up results

3. The differences and causes of colposcopic biopsy pathology and histology

4. Quality of colposcopy in our hospital （3）Retrospective study Data of out-patient population in our hospital from 2005 were included

Study Timeline

• Study Start: 2015-01-01
• Status Verified: 2023-11
• Primary Completion: 2025-01-01
• Study Completion: 2025-01-01
• Study First Submitted: 2025-01-25
• Study First Submitted QC: 2025-02-08
• Last Update Submitted: 2025-02-08
• Study First Posted: 2025-02-12
• Last Update Posted: 2025-02-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 10000

Inclusion Criteria

1. at least 18 years of age;
2. Complete colposcopy report;
3. Clear pathological diagnosis was reported after colposcopic biopsy.

Exclusion Criteria

1. Under 18 years of age;
2. Lack of colposcopic reports;
3. Lack of cervical biopsy pathology results;
4. Other conditions deemed inappropriate by the investigator to participate in this study.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Correlation between colposcopic results and histopathology	Since this study was a retrospective study, colposcopic biopsy results were available at the time of enrollment. Pathological results were available on average 14 days after colposcopy.	Each enrolled subject had a definite pathological report of cervical biopsy. Investigator analyzed the correlation between cervical cancer screening results and histopathology, and analyzed the overall quality of colposcopy.