Clinical Validation of Cervical Cancer Screening Methods

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Cervical Cancer, Cervical Dysplasia, Human Papilloma Virus

Intervention / Treatment
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* 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


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| High risk group<br>Women in the age group between 25 and 65 years old without prior history of malignancy referred to colposcopy | Diagnostic Test: Papanicolaou cytological test<br>* Cervical smear stained using conventional Papanicolaou technique.<br>Diagnostic Test: Local cytological test (H&E stain)<br>* Cervical smear stained using conventional hematoxylin and eosin staining techniques<br>Diagnostic Test: Validated HPV DNA Test<br>* Digene HC2 HPV DNA Test<br>Diagnostic Test: Local HPV test<br>* RealBest DNA HPV HR genotype (differential detection of human papillomavirus types 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59 DNA)<br>Diagnostic Test: Colposcopy<br>* Women with positive cytology results are referred to colposcopy and biopsy<br>|
| Population sample<br>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<br>* Cervical smear stained using conventional Papanicolaou technique.<br>Diagnostic Test: Local cytological test (H&E stain)<br>* Cervical smear stained using conventional hematoxylin and eosin staining techniques<br>Diagnostic Test: Validated HPV DNA Test<br>* Digene HC2 HPV DNA Test<br>Diagnostic Test: Local HPV test<br>* RealBest DNA HPV HR genotype (differential detection of human papillomavirus types 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59 DNA)<br>|

What is the study measuring?
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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 |