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Clinical Validation of Cervical Cancer Screening Methods

NCT04783649 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 2500

Last updated 2021-03-05

No results posted yet for this study

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.

Conditions

Interventions

DIAGNOSTIC_TEST

Papanicolaou cytological test

Cervical smear stained using conventional Papanicolaou technique.

DIAGNOSTIC_TEST

Local cytological test (H&E stain)

Cervical smear stained using conventional hematoxylin and eosin staining techniques

DIAGNOSTIC_TEST

Validated HPV DNA Test

Digene HC2 HPV DNA Test

DIAGNOSTIC_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)

DIAGNOSTIC_TEST

Colposcopy

Women with positive cytology results are referred to colposcopy and biopsy

Sponsors & Collaborators

  • N.N. Petrov National Medical Research Center of Oncology

    lead OTHER

Eligibility

Min Age
25 Years
Max Age
65 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-07-13
Primary Completion
2022-07-01
Completion
2023-07-01

Countries

  • Russia

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04783649 on ClinicalTrials.gov