NCT04783649

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
2,500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2020

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 13, 2020

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

March 2, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 5, 2021

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2022

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2023

Completed
Last Updated

March 5, 2021

Status Verified

March 1, 2021

Enrollment Period

2 years

First QC Date

March 2, 2021

Last Update Submit

March 2, 2021

Conditions

Cervical CancerCervical DysplasiaHuman Papilloma Virus

Outcome Measures

Primary Outcomes (2)

  • Sensitivity

    Cervical screening tests sensitivity

    24 months

  • Specificity

    Cervical screening tests specificity

    24 months

Secondary Outcomes (2)

  • HPV prevalence by type

    24 months

  • Cervical dysplasia prevalence

    24 months

Other Outcomes (2)

  • Safety of cervical smear

    24 months

  • Safety of colposcopy and biopsy

    24 months

Study Arms (2)

High risk group

Women in the age group between 25 and 65 years old without prior history of malignancy referred to colposcopy

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

Population sample

A population sample of women in the age group between 25 and 65 years old from several primary healthcare facilities to primary cervical screening

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

Interventions

Papanicolaou cytological testDIAGNOSTIC_TEST

Cervical smear stained using conventional Papanicolaou technique.

High risk groupPopulation sample
Local cytological test (H&E stain)DIAGNOSTIC_TEST

Cervical smear stained using conventional hematoxylin and eosin staining techniques

High risk groupPopulation sample
Validated HPV DNA TestDIAGNOSTIC_TEST

Digene HC2 HPV DNA Test

High risk groupPopulation sample
Local HPV testDIAGNOSTIC_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)

High risk groupPopulation sample
ColposcopyDIAGNOSTIC_TEST

Women with positive cytology results are referred to colposcopy and biopsy

High risk group

Eligibility Criteria

Age25 Years - 65 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsGender identity
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

25-65 year-old women without prior history of malignancy referred to colposcopy enriched with a population sample of women from several primary healthcare facilities.

You may qualify if:

  • Age between 25 and 65 years old Referral to colposcopy or to a primary screening test Signed informed consent

You may not qualify if:

  • Prior history of malignancy or cervical dysplasia Prior history of cervical dysplasia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

N.N. Petrov National Medical Research Center of Oncology

Saint Petersburg, 197758, Russia

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Cytology and biopsy samples

MeSH Terms

Conditions

Uterine Cervical NeoplasmsUterine Cervical Dysplasia

Interventions

Colposcopy

Condition Hierarchy (Ancestors)

Uterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsUterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesPrecancerous Conditions

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Obstetrical and GynecologicalDiagnostic Techniques and ProceduresDiagnosisEndoscopyDiagnostic Techniques, SurgicalMinimally Invasive Surgical ProceduresSurgical Procedures, OperativeObstetric Surgical ProceduresGynecologic Surgical ProceduresUrogenital Surgical Procedures

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 2, 2021

First Posted

March 5, 2021

Study Start

July 13, 2020

Primary Completion

July 1, 2022

Study Completion

July 1, 2023

Last Updated

March 5, 2021

Record last verified: 2021-03

Locations

RU(1)