Clinical Validation of Cervical Cancer Screening Methods

Cervical Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04783649
• Other study ID #: CC-001
• Status: Recruiting
• Start date: July 13, 2020
• Est. completion date: July 1, 2023

Study information

• Verified date: March 2021
• Source: N.N. Petrov National Medical Research Center of Oncology
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2500
• Est. completion date: July 1, 2023
• Est. primary completion date: July 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 25 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Cervical Cancer
• Cervical Dysplasia
• Cervical Intraepithelial Neoplasia
• Human Papilloma Virus
• Papilloma
• Uterine Cervical Dysplasia
• Uterine Cervical Neoplasms

Intervention

Diagnostic Test:
• Papanicolaou cytological test
Cervical smear stained using conventional Papanicolaou technique.
• Local cytological test (H&E stain)
Cervical smear stained using conventional hematoxylin and eosin staining techniques
• Validated HPV DNA Test
Digene HC2 HPV DNA 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)
• Colposcopy
Women with positive cytology results are referred to colposcopy and biopsy

Locations

Country	Name	City	State
Russian Federation	N.N. Petrov National Medical Research Center of Oncology	Saint Petersburg

Sponsors (1)

Lead Sponsor	Collaborator
N.N. Petrov National Medical Research Center of Oncology

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Safety of cervical smear	Adverse events after cervical smear	24 months
Other	Safety of colposcopy and biopsy	Adverse events after colposcopy and biopsy	24 months
Primary	Sensitivity	Cervical screening tests sensitivity	24 months
Primary	Specificity	Cervical screening tests specificity	24 months
Secondary	HPV prevalence by type	HPV prevalence by type based on genotyping in the population sample	24 months
Secondary	Cervical dysplasia prevalence	Prevalence of cervical dysplasia in the population sample	24 months