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Clinical Validation of Cervical Cancer Screening Methods

N

N.N. Petrov National Medical Research Center of Oncology

Status

Unknown

Conditions

Human Papilloma Virus
Cervical Dysplasia
Cervical Cancer

Treatments

Diagnostic Test: Colposcopy
Diagnostic Test: Local cytological test (H&E stain)
Diagnostic Test: Papanicolaou cytological test
Diagnostic Test: Validated HPV DNA Test
Diagnostic Test: Local HPV test

Study type

Observational

Funder types

Other

Identifiers

Details and patient eligibility

About

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.

Full 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.

Enrollment

2,500 estimated patients

Sex

Female

Ages

25 to 65 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

2,500 participants in 2 patient groups

High risk group
Description:
Women in the age group between 25 and 65 years old without prior history of malignancy referred to colposcopy
Treatment:
Diagnostic Test: Validated HPV DNA Test
Diagnostic Test: Papanicolaou cytological test
Diagnostic Test: Local cytological test (H&E stain)
Diagnostic Test: Colposcopy
Diagnostic Test: Local HPV test
Population sample
Description:
A population sample of women in the age group between 25 and 65 years old from several primary healthcare facilities to primary cervical screening
Treatment:
Diagnostic Test: Validated HPV DNA Test
Diagnostic Test: Papanicolaou cytological test
Diagnostic Test: Local cytological test (H&E stain)
Diagnostic Test: Local HPV test

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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