Clinical Validation of Cervical Cancer Screening Methods

Cervical Cancer Clinical Trial

Official title: Clinical Validation of Cervical Cancer Screening Methods in St. Petersburg, Russia

Status Recruiting

Clinical Trial Summary

This single-institution cross-sectional non-inferiority validation study evaluates alternative techniques and tests for primary cervical cancer screening programs in Russia, particularly: local cytology staining techniques, local HPV tests.

Clinical Trial Description

Cervical cytology practices are different across the world. While the Pap test became the cornerstone of the highly-effective cervical cancer screening in the countries that initially implemented population-based programs in the 60s and the 70s, alternative staining techniques were implemented in the Soviet Union. The tradition to apply other staining techniques than conventional Pap test remained unchanged in the national screening program implemented in the 2010s in Russia. As a new alternative option HPV testing showed effectiveness in screening women older than 30. The acceptable sensitivity and specificity of a screening test are crucial in population-based screening, that is why validation against "the gold standard" should be the first step in the process of program implementation. The objective of this study is to evaluate alternative techniques and tests for primary cervical cancer screening programs in Russia, particularly: local cytology staining techniques, local HPV tests in the population of 25-65 yo women without prior history of malignancy referred to colposcopy enriched with a population sample of women from several primary healthcare facilities referred to a primary screening test. ;

Related Conditions & MeSH terms

• Cervical Cancer
• Cervical Dysplasia
• Cervical Intraepithelial Neoplasia
• Human Papilloma Virus
• Papilloma
• Uterine Cervical Dysplasia
• Uterine Cervical Neoplasms

• NCT number: NCT04783649
• Study type: Observational
• Source: N.N. Petrov National Medical Research Center of Oncology
• Status: Recruiting
• Start date: July 13, 2020
• Completion date: July 1, 2023