Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Infections

Rare Diseases

Uterine Cervical Neoplasms

Uterine Cervical Dysplasia

Papilloma

Virus Diseases

Uterine Neoplasms

Genital Neoplasms, Female

Urogenital Neoplasms

Uterine Cervical Diseases

Uterine Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Neoplasms, Squamous Cell

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Precancerous Conditions

Cervical Intraepithelial Neoplasia

Women in the age group between 25 and 65 years old without prior history of malignancy referred to colposcopy

A population sample of women in the age group between 25 and 65 years old from several primary healthcare facilities to primary cervical screening

Cervical smear stained using conventional Papanicolaou technique.

Papanicolaou cytological test

Cervical smear stained using conventional hematoxylin and eosin staining techniques

Local cytological test (H&E stain)

Validated HPV DNA 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)

Local HPV test

Women with positive cytology results are referred to colposcopy and biopsy

Colposcopy

Olga Smirnova, MD, PhD

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.

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.

Clinical Validation of Cervical Cancer Screening Methods

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

Adverse events after colposcopy and biopsy

HPV prevalence by type based on genotyping in the population sample

Prevalence of cervical dysplasia in the population sample

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Clinical Validation of Cervical Cancer Screening Methods	NCT04783649	Cervical Cancer Cervical Dyspla... Human Papilloma...	Papanicolaou cy... Local cytologic... Validated HPV D... Local HPV test Colposcopy	25 Years - 65 Years	N.N. Petrov National Medical Research Center of Oncology
Clinical Validation of Cervical Cancer Screening Methods	NCT04783649	Cervical Cancer Cervical Dyspla... Human Papilloma...	Papanicolaou cy... Local cytologic... Validated HPV D... Local HPV test Colposcopy	25 Years - 65 Years	N.N. Petrov National Medical Research Center of Oncology

Spots Global Cancer Trial Database for local cytological test (h&e stain)