Cervical Cancer Clinical Trial
Official title:
A Retrospective Cohort Study on the Effectiveness of Various Screening Strategies for Uterine Cervical Cancer
| NCT number | NCT05309122 |
| Other study ID # | EVUCC |
| Secondary ID | |
| Status | Recruiting |
| Phase | |
| First received | |
| Last updated | |
| Start date | March 19, 2022 |
| Est. completion date | March 19, 2025 |
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+.
| Status | Recruiting |
| Enrollment | 10000 |
| Est. completion date | March 19, 2025 |
| Est. primary completion date | March 19, 2024 |
| Accepts healthy volunteers | No |
| Gender | Female |
| Age group | 18 Years and older |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| China | Lei Li | Beijing | Beijing |
| Lead Sponsor | Collaborator |
|---|---|
| Lei Li |
China,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | CIN2+ | CIN2+ detected by various screening methods | One year | |
| Secondary | Invasive procedures | Invasive procedures needed according to the screening results | One year | |
| Secondary | Vaginal intraepithelial neoplasia (VaIN) | VaIN detected by various screening methods | One year | |
| Secondary | Vulval intraepithelial neoplasia (VIN) | VIN detected by various screening methods | One year |
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