NCT04359420

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 study design will be used, whereby women from screening sites will be offered usual NHS Breast Screening Programme or BC-Predict for an eight month period, followed by a cross-over point where women at each site will be offered the other invention during an eight month period.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
32,298

participants targeted

Target at P75+ for not_applicable breast-cancer

Timeline
Completed

Started Aug 2019

Typical duration for not_applicable breast-cancer

Geographic Reach
1 country

1 active site

Status
completed

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

August 1, 2019

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

April 15, 2020

Completed
9 days until next milestone

First Posted

Study publicly available on registry

April 24, 2020

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 28, 2021

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2022

Completed
Last Updated

January 10, 2023

Status Verified

January 1, 2023

Enrollment Period

2.4 years

First QC Date

April 15, 2020

Last Update Submit

January 9, 2023

Conditions

Breast Cancer

Keywords

breast cancerScreeningrisk stratificationhigh riskpsychological impactearly detectionmammographic densitychemopreventionTyrer-Cuzickanxiety

Outcome Measures

Primary Outcomes (1)

  • Prescription of chemoprevention.

    Frequency of women taking up initial prescription of chemoprevention drugs (anastrozole/tamoxifen/raloxifene) from Family History, Risk and Prevention Clinic Data will be collected on each of the following aspects of this: (a) participant agrees/disagrees in clinic to take chemoprevention, (b) chemoprevention not appropriate, (c) chemoprevention appropriate but prescription not filled, (d) chemoprevention appropriate and prescription filled.

    6 months after screening appointment

Secondary Outcomes (9)

  • Screening attendance at first offered screening episode

    attendance within 6 weeks of first specific appointment offered

  • Screening attendance within 180 days

    within 180 days first appointment offered

  • number of recalls

    within 6 months of first appointment offered

  • Number of breast cancer diagnoses

    within 6 months of first appointment offered

  • Uptake of consultation at Family History, Risk and Prevention clinics

    within 6 months of first appointment offered

  • +4 more secondary outcomes

Other Outcomes (2)

  • Cost consequences

    at 6 months of first appointment offered

  • Variation in uptake of services offered examined by deciles of index of multiple deprivation (as assessed using residential postcode)

    at 6 months of first appointment

Study Arms (2)

BC-Predict

EXPERIMENTAL

Women will be sent an invitation letter one to two days after their breast screening invitation letter, directing prospective participants to the online risk assessment platform. Once participants have consented to the study online, they will be directed to the BC-Predict risk assessment questionnaire. Assessment of the online questionnaire during the pilot phase estimated that most women would be able to complete this within 30 minutes. Women who complete the questionnaire will receive 10-year breast cancer risk estimates once they have screened negative for breast cancer, based on the Tyrer-Cuzick model, incorporating mammographic density, and for some women, SNPs (single nucleotide polymorphisms). Women who are identified as being at "high" (\>8%) or "moderate" (5% and \<8%) 10-year risk will be offered a consultation to discuss prevention options including prescription of chemoprevention drugs and/ or more frequent mammography as part of the NHS Breast Screening Programme.

Other: BC-Predict

NHS-Breast Screening Programme

ACTIVE COMPARATOR

Usual care in the NHS Breast Screening Programme, which involves mammography every 3 years for the majority of women

Other: NHS Breast Screening Programme

Interventions

BC-PredictOTHER

BC-Predict is an automated system for offering an assessment of breast cancer risk to women when they receive their NHS Breast Screening Programme invitation, and generating letters to feedback this risk to women and relevant healthcare professionals. Women at higher risk are offered chemoprevention drugs and additional mammography

Also known as: risk stratified screening
BC-Predict
NHS Breast Screening ProgrammeOTHER

usual care from NHS Breast Screening Programme, consisting of mammography every three years for most women.

NHS-Breast Screening Programme

Eligibility Criteria

Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Manchester University NHS Foundation Trust

Manchester, Greater Manchester, M23 9LT, United Kingdom

Location

Related Publications (3)

  • Gareth Evans D, McWilliams L, Astley S, Brentnall AR, Cuzick J, Dobrashian R, Duffy SW, Gorman LS, Harkness EF, Harrison F, Harvie M, Jerrison A, Machin M, Maxwell AJ, Howell SJ, Wright SJ, Payne K, Qureshi N, Ruane H, Southworth J, Fox L, Bowers S, Hutchinson G, Thorpe E, Ulph F, Woof V, Howell A, French DP. Quantifying the effects of risk-stratified breast cancer screening when delivered in real time as routine practice versus usual screening: the BC-Predict non-randomised controlled study (NCT04359420). Br J Cancer. 2023 Jun;128(11):2063-2071. doi: 10.1038/s41416-023-02250-w. Epub 2023 Apr 1.

    PMID: 37005486DERIVED

  • Pegington M, Harvie M, Harkness EF, Brentnall A, Malcomson L, Southworth J, Fox J, Howell A, Cuzick J, Evans DG. Obesity at age 20 and weight gain during adulthood increase risk of total and premature all-cause mortality: findings from women attending breast screening in Manchester. BMC Womens Health. 2023 Jan 13;23(1):17. doi: 10.1186/s12905-023-02162-0.

    PMID: 36635680DERIVED

  • French DP, Astley S, Brentnall AR, Cuzick J, Dobrashian R, Duffy SW, Gorman LS, Harkness EF, Harrison F, Harvie M, Howell A, Jerrison A, Machin M, Maxwell AJ, McWilliams L, Payne K, Qureshi N, Ruane H, Sampson S, Stavrinos P, Thorpe E, Ulph F, van Staa T, Woof V, Evans DG. What are the benefits and harms of risk stratified screening as part of the NHS breast screening Programme? Study protocol for a multi-site non-randomised comparison of BC-predict versus usual screening (NCT04359420). BMC Cancer. 2020 Jun 18;20(1):570. doi: 10.1186/s12885-020-07054-2.

    PMID: 32552763DERIVED

MeSH Terms

Conditions

Breast NeoplasmsAnxiety Disorders

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesMental Disorders

Study Officials

  • Gareth Evans, MD

    Manchester University NHS Foundation Trust

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
SEQUENTIAL
Model Details: A non-randomised fully counterbalanced study design will be used, to include equal numbers of participants from all sites who will be offered NHS-BSP and BC-Predict. Specifically, in the initial 8-month time period, women eligible for breast screening in three screening sites will be offered BC-Predict, whilst women in two screening sites are offered usual NHS-BSP. In the following 8-month time period the study sites switch to offer the other intervention (NHS-BSP rather than BC-Predict; and vice versa). This will allow estimates of effect to be obtained from both within-sample and between-sample analyses.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof David French

Study Record Dates

First Submitted

April 15, 2020

First Posted

April 24, 2020

Study Start

August 1, 2019

Primary Completion

December 28, 2021

Study Completion

June 30, 2022

Last Updated

January 10, 2023

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will not share

Data will be shared in anonymised format with bone fide researchers, once main outcomes from the study have been published.

Locations

GB(1)