NCT04783649

Clinical Validation of Cervical Cancer Screening Methods

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 2,500 (estimated)
• Sponsor: N.N. Petrov National Medical Research Center of Oncology · Academic / Other
• Sex: Female
• Age: 25 Years – 65 Years
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• Cervical Cancer
• Cervical Dysplasia
• Human Papilloma Virus

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Papanicolaou cytological test	Cervical smear stained using conventional Papanicolaou technique.
DIAGNOSTIC_TEST	Local cytological test (H&E stain)	Cervical smear stained using conventional hematoxylin and eosin staining techniques
DIAGNOSTIC_TEST	Validated HPV DNA Test	Digene HC2 HPV DNA Test
DIAGNOSTIC_TEST	Local HPV test	RealBest DNA HPV HR genotype (differential detection of human papillomavirus types 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59 DNA)
DIAGNOSTIC_TEST	Colposcopy	Women with positive cytology results are referred to colposcopy and biopsy

Timeline

• Start date: 2020-07-13
• Primary completion: 2022-07-01
• Completion: 2023-07-01
• First posted: 2021-03-05
• Last updated: 2021-03-05

Locations

1 site across 1 country: Russia