Quality Control of Colposcopy Application (QCCA)

February 8, 2025 updated by: Peking Union Medical College Hospital

Quality Control of Colposcopy Application: a Retrospective Cohort Study in China

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

10000

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

The outpatient population of our hospital since 2005 10,000 cases are expected to be included.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Correlation between colposcopic results and histopathology
Time Frame: 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.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking Union Medical College Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2015

Primary Completion (Actual)

January 1, 2025

Study Completion (Actual)

January 1, 2025

Study Registration Dates

First Submitted

January 25, 2025

First Submitted That Met QC Criteria

February 8, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 8, 2025

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • K4900

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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