Cervical Cancer Screening Strategies

Sponsor
Lei Li (Other)
Overall Status
Recruiting
CT.gov ID
NCT05309122
Collaborator
(none)
10,000
1
36
277.7

Study Details

Study Description

Brief 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. 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

Study Type:
Observational
Anticipated Enrollment :
10000 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
A Retrospective Cohort Study on the Effectiveness of Various Screening Strategies for Uterine Cervical Cancer
Actual Study Start Date :
Mar 19, 2022
Anticipated Primary Completion Date :
Mar 19, 2024
Anticipated Study Completion Date :
Mar 19, 2025

Outcome Measures

Primary Outcome Measures

  1. CIN2+ [One year]

    CIN2+ detected by various screening methods

Secondary Outcome Measures

  1. Invasive procedures [One year]

    Invasive procedures needed according to the screening results

  2. Vaginal intraepithelial neoplasia (VaIN) [One year]

    VaIN detected by various screening methods

  3. Vulval intraepithelial neoplasia (VIN) [One year]

    VIN detected by various screening methods

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Aged 18 years or older

  • With definite cervical histology after cervical cancer screening, ore with at least one screening test after first testing

Exclusion Criteria:
  • Not meeting all of the inclusion criteria

Contacts and Locations

Locations

Site City State Country Postal Code
1 Lei Li Beijing Beijing China 100730

Sponsors and Collaborators

  • Lei Li

Investigators

  • Principal Investigator: Lei Li, M.D., Peking Union Medical College Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Lei Li, Professor, Peking Union Medical College Hospital
ClinicalTrials.gov Identifier:
NCT05309122
Other Study ID Numbers:
  • EVUCC
First Posted:
Apr 4, 2022
Last Update Posted:
Apr 4, 2022
Last Verified:
Mar 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 4, 2022