Cervical Cancer, Cervical Dysplasia, Human Papilloma Virus
Conditions
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.
Interventions
DIAGNOSTIC_TESTPapanicolaou cytological test
Cervical smear stained using conventional Papanicolaou technique.
DIAGNOSTIC_TESTLocal cytological test (H&E stain)
Cervical smear stained using conventional hematoxylin and eosin staining techniques
DIAGNOSTIC_TESTValidated HPV DNA Test
Digene HC2 HPV DNA Test
DIAGNOSTIC_TESTLocal 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_TESTColposcopy
Women with positive cytology results are referred to colposcopy and biopsy
Sponsors
N.N. Petrov National Medical Research Center of Oncology
Study design
Observational model
COHORT
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
FEMALE
Age
25 Years to 65 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sensitivity | 24 months | Cervical screening tests sensitivity |
| Specificity | 24 months | Cervical screening tests specificity |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| HPV prevalence by type | 24 months | HPV prevalence by type based on genotyping in the population sample |
| Cervical dysplasia prevalence | 24 months | Prevalence of cervical dysplasia in the population sample |
Other
| Measure | Time frame | Description |
|---|---|---|
| Safety of cervical smear | 24 months | Adverse events after cervical smear |
| Safety of colposcopy and biopsy | 24 months | Adverse events after colposcopy and biopsy |
Countries
Russia
Outcome results
None listed