Clinical Validation of Cervical Cancer Screening Methods
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
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 Design
Arms and Interventions
| Arm | 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)
|
Outcome Measures
Primary Outcome Measures
- Sensitivity [24 months]
Cervical screening tests sensitivity
- Specificity [24 months]
Cervical screening tests specificity
Secondary Outcome Measures
- 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 Outcome Measures
- Safety of cervical smear [24 months]
Adverse events after cervical smear
- Safety of colposcopy and biopsy [24 months]
Adverse events after colposcopy and biopsy
Eligibility Criteria
Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | N.N. Petrov National Medical Research Center of Oncology | Saint Petersburg | Russian Federation | 197758 |
Sponsors and Collaborators
- N.N. Petrov National Medical Research Center of Oncology
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CC-001