Cervical CancerNCT05309122
Cervical Cancer Screening Strategies
An observational study of Cervical Cancer and Cervical Intraepithelial Neoplasia, run by Lei Li at 1 site in China.
Trial summary
This study is to investigate retrospectively the results of cervical cytology and high-risk human papillomavirus in the past 20 years recorded in Peking Union Medical College Hospital. The histological findings after cervical cancer screening were reviewed. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Cervical Cancer, Cervical Intraepithelial Neoplasia, Human Papillomavirus Infection
- How many people
- 10,000 participants
- Where
- 1 siteChina
- Study dates
- 19 Mar 2022to 19 Mar 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: Participants who accepted cervical cancer screening in the study center
Who may be able to join
- Aged 18 years or older
- With definite cervical histology after cervical cancer screening, ore with at least one screening test after first testing
Who cannot join
- Not meeting all of the inclusion criteria
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Lei Li
Beijing, Beijing Municipality, 100730
Lei Li, MD, 008613911988831, lileigh@163.com
About this study
Official title: A Retrospective Cohort Study on the Effectiveness of Various Screening Strategies for Uterine Cervical Cancer
This study is to investigate retrospectively the results of cervical cytology and high-risk human papillomavirus in the past 20 years recorded in Peking Union Medical College Hospital. The histological findings after cervical cancer screening were reviewed. The diagnostic values of different screening strategies were compared based on the results of cervical histology. The primary endpoint is the diagnosis of grade 2 cervical intraepithelial neoplasia (CIN2) or more severe lesions (CIN2+). The secondary endpoints include following objectives: (1) the invasive procedures needed according to the screening results; (2) the diagnosis of vaginal and/or vulval intraepithelial neoplasia; (3) the persistence and recurrence of human papillomavirus infection; and (4) the cost-effectiveness of screening strategies for CIN2+.
- Conditions
- Cervical Cancer, Cervical Intraepithelial Neoplasia, Human Papillomavirus Infection, Cervical Cytology, Cancer Screening
- Medical subject headings
- Uterine Cervical Neoplasms, Uterine Cervical Dysplasia, Papillomavirus Infections
What is being measured
The primary outcome is the main question the study is designed to answer.
CIN2+
CIN2+ detected by various screening methods
Measured: One year
Secondary outcomes (3)
Invasive procedures
Invasive procedures needed according to the screening results
Measured: One year
Vaginal intraepithelial neoplasia (VaIN)
VaIN detected by various screening methods
Measured: One year
Vulval intraepithelial neoplasia (VIN)
VIN detected by various screening methods
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2022
- Study start19 Mar 2022
- Primary completion19 Mar 2024 (estimated)
- Study completion19 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical CancerStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 10,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lei Li
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Lei Li, Peking Union Medical College Hospital
- Investigators
- Lei Li, M.D., Principal investigator, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05309122
- Sponsor's protocol ID
- EVUCC
- Status last verified
- Mar 2022
- First submitted
- 25 Mar 2022
- Last updated
- 4 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Retrospective Cohort Study on the Effectiveness of Various Screening Strategies for Uterine Cervical Cancer
- ClinicalTrials.gov ID
- NCT05309122
- Acronym / sponsor ID
- EVUCC
- Conditions
- Cervical Cancer, Cervical Intraepithelial Neoplasia, Human Papillomavirus Infection, Cervical Cytology, Cancer Screening
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 10,000 participants (estimated)
- Lead sponsor
- Lei LiUniversity, hospital or other
- Study start
- 19 Mar 2022 (actual)
- Primary completion
- 19 Mar 2024 (estimated)
- Study completion
- 19 Mar 2025 (estimated)
- First posted
- 4 Apr 2022 (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.
This study is to investigate retrospectively the results of cervical cytology and high-risk human papillomavirus in the past 20 years recorded in Peking Union Medical College Hospital. The histological findings after cervical cancer screening were reviewed. The diagnostic values of different screening strategies were compared based on the results of cervical histology. The primary endpoint is the diagnosis of grade 2 cervical intraepithelial neoplasia (CIN2) or more severe lesions (CIN2+). The secondary endpoints include following objectives: (1) the invasive procedures needed according to the screening results; (2) the diagnosis of vaginal and/or vulval intraepithelial neoplasia; (3) the persistence and recurrence of human papillomavirus infection; and (4) the cost-effectiveness of screening strategies for CIN2+.
Study design
- Observational model
- Cohort
- 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
- Participants who accepted cervical cancer screening in the study center
Key inclusion criteria (2 listed)
- Aged 18 years or older
- With definite cervical histology after cervical cancer screening, ore with at least one screening test after first testing
Key exclusion criteria (1 listed)
- Not meeting all of the inclusion criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
CIN2+
Time frame: One year
CIN2+ detected by various screening methods
3 secondary outcomes
Invasive procedures
Time frame: One year
Vaginal intraepithelial neoplasia (VaIN)
Time frame: One year
Vulval intraepithelial neoplasia (VIN)
Time frame: One year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2022.
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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.
Lei Li, M.D. principal investigator
Peking Union Medical College Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cervical Cancer and Cervical Intraepithelial Neoplasia, run by Lei Li at 1 site in China.
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 2 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 4 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lei Li, M.D. (86-139-1198-8831, lileigh@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CIN2+ (time frame: One year). 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 4 Apr 2022.