Cervical Cancer Screening Strategies

NCT05309122 | Unknown

• 1 other identifier: EVUCC
• Study Type: observational
• Target: 10,000
• Locations: 1 country
• Sites: 1

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+.

Conditions

Cervical Cancer; Cervical Intraepithelial Neoplasia; Human Papillomavirus Infection; Cervical Cytology; Cancer Screening

Outcome Measures

Primary Outcomes (1)

• CIN2+

  CIN2+ detected by various screening methods

  One year

Secondary Outcomes (3)

• Invasive procedures

  One year

• Vaginal intraepithelial neoplasia (VaIN)

  One year

• Vulval intraepithelial neoplasia (VIN)

  One year

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants who accepted cervical cancer screening in the study center

You may qualify if:

• Aged 18 years or older
• With definite cervical histology after cervical cancer screening, ore with at least one screening test after first testing

Sponsors & Collaborators

• Lei Li: lead

Study Sites (1)

Lei Li

Beijing, Beijing Municipality, 100730, China

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Cervical exfoliated cells collected by pap smear or by Thinprep cytology testing

MeSH Terms

Conditions

Uterine Cervical Neoplasms; Uterine Cervical Dysplasia; Papillomavirus Infections

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Precancerous Conditions; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Communicable Diseases; Infections; DNA Virus Infections; Virus Diseases; Tumor Virus Infections; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Lei Li, M.D.

  Peking Union Medical College Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lei Li, M.D.

CONTACT

86-139-1198-8831; lileigh@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 25, 2022
• First Posted: April 4, 2022
• Study Start: March 19, 2022
• Primary Completion: March 19, 2024
• Study Completion: March 19, 2025
• Last Updated: April 4, 2022

Record last verified: 2022-03

Locations

CN (1)