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Spots Global Cancer Trial Database for Clinical Validation of Cervical Cancer Screening Methods

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Trial Identification

Brief Title: Clinical Validation of Cervical Cancer Screening Methods

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

Study ID: NCT04783649

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.

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.

Keywords

Eligibility

Minimum Age: 25 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: FEMALE

Healthy Volunteers: Yes

Locations

N.N. Petrov National Medical Research Center of Oncology, Saint Petersburg, , Russian Federation

Contact Details

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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