NCT03721484

Brief Summary

Prospective study which will recruit participants when they attend for a routine cervical screening. The study will evaluate the use of CINtec PLUS for triage of human papillomavirus (HPV) positive participants in HPV primary screening.

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
9,800

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2019

Typical duration for not_applicable

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

First Submitted

Initial submission to the registry

October 17, 2018

Completed
9 days until next milestone

First Posted

Study publicly available on registry

October 26, 2018

Completed
2 months until next milestone

Study Start

First participant enrolled

January 1, 2019

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2020

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2021

Completed
Last Updated

October 26, 2018

Status Verified

October 1, 2018

Enrollment Period

1.5 years

First QC Date

October 17, 2018

Last Update Submit

October 24, 2018

Conditions

Cervical Cancer

Outcome Measures

Primary Outcomes (2)

  • Risk of high-grade disease

    CIN2+ diagnosed on biopsy obtained at colposcopy.

    3 years

  • Risk of low-grade disease

    \<CIN2 as determined by colposcopy assessment/biopsy or cytology ≤Mild/HPV negative.

    3 years

Interventions

CINtec PLUSDIAGNOSTIC_TEST

CINtec PLUS testing will be used to triage HPV positive women to colposcopy

Eligibility Criteria

Age25 Years - 64 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Consenting women aged 25y-64y attending for cervical screening

You may not qualify if:

  • Women aged \<25y and \>64y

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

WHSCT

Londonderry, Northern Ireland, BT476SB, United Kingdom

Location

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Condition Hierarchy (Ancestors)

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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr.

Study Record Dates

First Submitted

October 17, 2018

First Posted

October 26, 2018

Study Start

January 1, 2019

Primary Completion

July 1, 2020

Study Completion

December 1, 2021

Last Updated

October 26, 2018

Record last verified: 2018-10

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)