Cervical CancersQCCANCT06823817
Quality Control of Colposcopy Application
An observational study of Cervical Cancers and Cervical Intraepithelial Neoplasia (CIN), run by Peking Union Medical College Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Cervical Cancers, Cervical Intraepithelial Neoplasia (CIN)
- What is being tested?
- colpscope
- How many people
- 10,000 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2015to 1 Jan 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: The outpatient population of our hospital since 2005 10,000 cases are expected to be included.
Who may be able to join
- at least 18 years of age;
- Complete colposcopy report;
- Clear pathological diagnosis was reported after colposcopic biopsy.
Who cannot join
- Under 18 years of age;
- Lack of colposcopic reports;
- Lack of cervical biopsy pathology results;
- Other conditions deemed inappropriate by the investigator to participate in this study.
About this study
Official title: 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.
Read the detailed description
- 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
- study purpose Main purpose
1）analyze the correlation between colposcopy indications and pathological findings Secondary purpose
- Influence of colposcopic transformation area type on pathological evaluation
- Colposcopic follow-up results
- The differences and causes of colposcopic biopsy pathology and histology
- Quality of colposcopy in our hospital （3）Retrospective study Data of out-patient population in our hospital from 2005 were included
- Being tested
- colpscope
- Keywords
- Cervical Cancers, Cervical Intraepithelial Neoplasia
- Medical subject headings
- Uterine Cervical Neoplasms, Uterine Cervical Dysplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
colpscopeDiagnostic test
Colposcopic cervical biopsy
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation between colposcopic results and histopathology
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.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2025
- Study start1 Jan 2015
- Primary completion1 Jan 2025
- Study completion1 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical CancersStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 10,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06823817
- Sponsor's protocol ID
- K4900
- Acronym
- QCCA
- Status last verified
- Nov 2023
- First submitted
- 25 Jan 2025
- Last updated
- 12 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quality Control of Colposcopy Application: a Retrospective Cohort Study in China
- ClinicalTrials.gov ID
- NCT06823817
- Acronym / sponsor ID
- QCCA / K4900
- Keywords
- Cervical Cancers, Cervical Intraepithelial Neoplasia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10,000 participants (actual)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- 1 Jan 2015 (actual)
- Primary completion
- 1 Jan 2025 (actual)
- Study completion
- 1 Jan 2025 (actual)
- First posted
- 12 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- 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
- study purpose Main purpose
1）analyze the correlation between colposcopy indications and pathological findings Secondary purpose
- Influence of colposcopic transformation area type on pathological evaluation
- Colposcopic follow-up results
- The differences and causes of colposcopic biopsy pathology and histology
- Quality of colposcopy in our hospital （3）Retrospective study Data of out-patient population in our hospital from 2005 were included
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The outpatient population of our hospital since 2005 10,000 cases are expected to be included.
Key inclusion criteria (3 listed)
- at least 18 years of age;
- Complete colposcopy report;
- Clear pathological diagnosis was reported after colposcopic biopsy.
Key exclusion criteria (4 listed)
- Under 18 years of age;
- Lack of colposcopic reports;
- Lack of cervical biopsy pathology results;
- Other conditions deemed inappropriate by the investigator to participate in this study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| colpscopeColposcopic cervical biopsy | Diagnostic test | – |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Cervical Cancers and Cervical Intraepithelial Neoplasia (CIN), run by Peking Union Medical College Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2025.