Brief Title
Clinical Validation of Cervical Cancer Screening Methods
Official Title
Clinical Validation of Cervical Cancer Screening Methods in St. Petersburg, Russia
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.
Study Type
Observational
Primary Outcome
Sensitivity
Secondary Outcome
HPV prevalence by type
Condition
Cervical Cancer
Intervention
Papanicolaou cytological test
Study Arms / Comparison Groups
High risk group
Description: Women in the age group between 25 and 65 years old without prior history of malignancy referred to colposcopy
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Diagnostic Test
Estimated Enrollment
2500
Start Date
July 13, 2020
Completion Date
July 1, 2023
Primary Completion Date
July 1, 2022
Eligibility 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
Gender
Female
Ages
25 Years - 65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Contacts
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Location Countries
Russian Federation
Location Countries
Russian Federation
Administrative Informations
NCT ID
NCT04783649
Organization ID
CC-001
Responsible Party
Sponsor
Study Sponsor
N.N. Petrov National Medical Research Center of Oncology
Study Sponsor
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Verification Date
March 2021