Clinical Validation of Cervical Cancer Screening Methods

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

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.

Study Overview

• Status: Recruiting
• Conditions: Cervical Cancer; Human Papilloma Virus; Cervical Dysplasia
• Intervention / Treatment: 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

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 Type: Observational
• Enrollment (Anticipated): 2500

Contacts and Locations

Study Locations

• Russian Federation
  • Saint Petersburg, Russian Federation, 197758
    • Recruiting
    • N.N. Petrov National Medical Research Center of Oncology
    • Contact: Olga Smirnova, MD, PhD; Phone Number: +7 812 439 9555; Email: ssmirnova.oa@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

25-65 year-old women without prior history of malignancy referred to colposcopy enriched with a population sample of women from several primary healthcare facilities.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
High risk group; Women in the age group between 25 and 65 years old without prior history of malignancy referred to colposcopy	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
Population sample; A population sample of women in the age group between 25 and 65 years old from several primary healthcare facilities to primary cervical screening	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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sensitivity	Cervical screening tests sensitivity	24 months
Specificity	Cervical screening tests specificity	24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
HPV prevalence by type	HPV prevalence by type based on genotyping in the population sample	24 months
Cervical dysplasia prevalence	Prevalence of cervical dysplasia in the population sample	24 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety of cervical smear	Adverse events after cervical smear	24 months
Safety of colposcopy and biopsy	Adverse events after colposcopy and biopsy	24 months

Collaborators and Investigators

• Sponsor: N.N. Petrov National Medical Research Center of Oncology

Study record dates

Study Major Dates

• Study Start (Actual): July 13, 2020
• Primary Completion (Anticipated): July 1, 2022
• Study Completion (Anticipated): July 1, 2023

Study Registration Dates

• First Submitted: March 2, 2021
• First Submitted That Met QC Criteria: March 2, 2021
• First Posted (Actual): March 5, 2021

Study Record Updates

• Last Update Posted (Actual): March 5, 2021
• Last Update Submitted That Met QC Criteria: March 2, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Carcinoma; Neoplasms, Glandular and Epithelial; Uterine Neoplasms; Genital Neoplasms, Female; Uterine Cervical Diseases; Uterine Diseases; Precancerous Conditions; Neoplasms, Squamous Cell; Carcinoma in Situ; Uterine Cervical Neoplasms; Cervical Intraepithelial Neoplasia; Uterine Cervical Dysplasia; Papilloma
• Other Study ID Numbers: CC-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No