Status:

COMPLETED

What Are the Benefits and Harms of Risk Stratified Screening in the NHS Breast Screening Programme: Study Protocol

Lead Sponsor:

University of Manchester

Collaborating Sponsors:

National Institute for Health Research, United Kingdom

Breast Cancer Now

Conditions:

Breast Cancer

Eligibility:

FEMALE

Phase:

NA

Brief Summary

This study aims to identify key benefits and harms of integrating risk stratification (the BC-Predict intervention) into the NHS Breast Screening Programme. A non-randomised fully counterbalanced stud...

Detailed Description

In principle, risk-stratification as a routine part of the NHS breast screening programme (NHS-BSP) should produce a better balance of benefits and harms. The main benefit is the offer of NICE (Nation...

Eligibility Criteria

Inclusion

  • born biologically female,
  • invited for either (a) first breast screening appointment (any age) or: (b) aged 57-63 years (only at East Cheshire and East Lancashire breast screening programmes),
  • able to provide informed consent and complete a risk assessment questionnaire.

Exclusion

  • previously has had breast cancer,
  • has had bilateral mastectomy, or
  • has previously participated in the related PROCAS (Predicting Risk Of Cancer At Screening) study

Key Trial Info

Start Date :

August 1 2019

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

June 30 2022

Estimated Enrollment :

32298 Patients enrolled

Trial Details

Trial ID

NCT04359420

Start Date

August 1 2019

End Date

June 30 2022

Last Update

January 10 2023

Active Locations (1)

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Page 1 of 1 (1 locations)

1

Manchester University NHS Foundation Trust

Manchester, Greater Manchester, United Kingdom, M23 9LT

What Are the Benefits and Harms of Risk Stratified Screening in the NHS Breast Screening Programme: Study Protocol | DecenTrialz