Clinical Validation of Cervical Cancer Screening Methods

• Conditions: Human Papilloma Virus; Cervical Cancer; Cervical Dysplasia
• Interventions: Diagnostic Test: Papanicolaou cytological test; Diagnostic Test: Local cytological test (H&E stain); Diagnostic Test: Validated HPV DNA Test; Diagnostic Test: Local HPV test; Diagnostic Test: Colposcopy

• Registration Number: NCT04783649
• Lead Sponsor: N.N. Petrov National Medical Research Center of Oncology

Brief 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.

Study Timeline

• Study Start: 2020-07-13
• Status Verified: 2021-03
• Study First Submitted: 2021-03-02
• Study First Submitted QC: 2021-03-02
• Last Update Submitted: 2021-03-02
• Study First Posted: 2021-03-05
• Last Update Posted: 2021-03-05
• Primary Completion: 2022-07-01
• Study Completion: 2023-07-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 2500

Inclusion Criteria

Age between 25 and 65 years old Referral to colposcopy or to a primary screening test Signed informed consent

Exclusion Criteria

Prior history of malignancy or cervical dysplasia Prior history of cervical dysplasia

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
High risk group	Papanicolaou cytological test	Women in the age group between 25 and 65 years old without prior history of malignancy referred to colposcopy
High risk group	Local cytological test (H&E stain)	Women in the age group between 25 and 65 years old without prior history of malignancy referred to colposcopy
High risk group	Validated HPV DNA Test	Women in the age group between 25 and 65 years old without prior history of malignancy referred to colposcopy
High risk group	Local HPV test	Women in the age group between 25 and 65 years old without prior history of malignancy referred to colposcopy
High risk group	Colposcopy	Women in the age group between 25 and 65 years old without prior history of malignancy referred to colposcopy
Population sample	Papanicolaou cytological test	A population sample of women in the age group between 25 and 65 years old from several primary healthcare facilities to primary cervical screening
Population sample	Local cytological test (H&E stain)	A population sample of women in the age group between 25 and 65 years old from several primary healthcare facilities to primary cervical screening
Population sample	Validated HPV DNA Test	A population sample of women in the age group between 25 and 65 years old from several primary healthcare facilities to primary cervical screening
Population sample	Local HPV test	A population sample of women in the age group between 25 and 65 years old from several primary healthcare facilities to primary cervical screening

Primary Outcome Measures

Name	Time	Method
Sensitivity	24 months	Cervical screening tests sensitivity
Specificity	24 months	Cervical screening tests specificity

Secondary Outcome Measures

Name	Time	Method
Cervical dysplasia prevalence	24 months	Prevalence of cervical dysplasia in the population sample
HPV prevalence by type	24 months	HPV prevalence by type based on genotyping in the population sample

Trial Locations

Locations (1)

N.N. Petrov National Medical Research Center of Oncology; 🇷🇺 Saint Petersburg, Russian Federation