CINtec PLUS Triage in HPV Primary Screening

NCT ID: NCT03721484

Last Updated: 2018-10-26

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 9800 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-01-31
• Study Completion Date: 2021-12-31

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.

Detailed Description

The study will recruit participants (9800) prospectively by verbal invitation from the sample taker when they attend for their cervical screening test. Recruitment will take up to one year to complete. Participants in the study will undergo primary HPV testing. This will be followed by cervical cytology testing as per the normal National Health Service Cervical Screening Programme (NHSCSP) screening invitation pathway. Participants testing HPV negative will have reached their end point and will exit the study. Participants who test HPV positive will be triaged by cytology (the cytology screening result, available through the NHSCSP screen will be used). Participants with moderate or severe dyskaryosis (high-grade disease) will be immediately referred to colposcopy (as per NHSCSP guidelines) without further testing. Participants with borderline or mild dyskaryosis (low-grade findings) will undergo CINtec PLUS Cytology triage simulation; however, regardless of the CINtec PLUS result, all participants will also be referred to colposcopy as per NHSCSP guidelines. Participants with negative cytology will undergo CINtec PLUS Cytology triage and those testing positive (an indication of increased risk of CIN2+ [high-grade disease]) will be referred to colposcopy. Participants with negative cytology who also test CINtec PLUS negative will only be referred to colposcopy if they have tested positive for HPV16 or HPV18 as these 2 genotypes have been shown to confer an elevated risk for CIN2+ compared with the other HPV types. Participants with negative cytology who also test CINtec PLUS negative and have tested positive for non HPV16 and HPV18 types will undergo repeat HPV testing at 12 months as the low risk of CIN2+ associated with these participants does not justify immediate colposcopy referral and is unlikely to be granted ethical approval.

Clinical outcomes based on colposcopy and/or histology and/or cervical cytology will be recorded. All biopsies will have one slide stained with CINtec Histology (p16). The risk of CIN2+ will be evaluated for all participants in the study. Subsequently, clinical performance of CINtec PLUS Cytology will be evaluated.

This work will also include a cost analysis.

Conditions

Cervical Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Interventions

CINtec PLUS

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

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• Women aged <25y and >64y

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 64 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Roche Pharma AG

INDUSTRY

Sponsor Role: collaborator

Western Health and Social Care Trust

OTHER

Sponsor Role: lead

Responsible Party

Dr. Mary McMenamin

Dr.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

WHSCT

Londonderry, Northern Ireland, United Kingdom

Countries

United Kingdom

Other Identifiers

v1.0

Identifier Type: -

Identifier Source: org_study_id