Ignite Creation Date:
2024-05-06 @ 5:25 PM
Last Modification Date:
2024-10-26 @ 2:28 PM
Study NCT ID:
NCT05305963
Status:
RECRUITING
Last Update Posted:
2023-07-10
First Post:
2022-03-14
Brief Title:
Breast CANcer Risk Assessment in Younger Women BCAN-RAY
Sponsor:
Manchester University NHS Foundation Trust
Organization:
Manchester University NHS Foundation Trust
Study Overview
Official Title:
A Case Control Study of Women Aged 30-39 to Augment Breast Cancer Risk Prediction and Assess Acceptability and Preference of a Systematic Risk Prediction Approach Through Primary Care
Status:
RECRUITING
Status Verified Date:
2023-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
BCAN-RAY
Brief Summary:
The overarching aim of the proposed research is to develop a comprehensive breast cancer risk assessment strategy for women aged 30-39 years
There are three main objectives to the study
Objective 1 - Mammographic Density and Risk To define the magnitude of BC risk associated with MD in women aged 30-39 and facilitate its incorporation into risk prediction models
Objective 2 - Psychological impact
To examine the feasibility of a strategy to offer breast cancer risk-assessment to diverse ethnic and socioeconomic populations of women in their 30s assessing
Potential benefits and harms
Impact on health inequalities
Acceptability
Objective 3 - DNA Methylation substudy To explore the potential of DNA Methylation DNAme signatures from self-obtained cervical samples to further refine risk prediction algorithms
There are three main objectives to the study
Objective 1 - Mammographic Density and Risk To define the magnitude of BC risk associated with MD in women aged 30-39 and facilitate its incorporation into risk prediction models
Objective 2 - Psychological impact
To examine the feasibility of a strategy to offer breast cancer risk-assessment to diverse ethnic and socioeconomic populations of women in their 30s assessing
Potential benefits and harms
Impact on health inequalities
Acceptability
Objective 3 - DNA Methylation substudy To explore the potential of DNA Methylation DNAme signatures from self-obtained cervical samples to further refine risk prediction algorithms
Detailed Description:
Breast cancer BC is the most common cause of female cancer death worldwide Incidence and mortality rates rise exponentially from age 30-50 figure CRUK 2021 and BC is the most common of any cause of death in women in this age group
The reasons for this dramatic increase in incidence in young women are not well understood and contrast with other endocrine sensitive organs endometrium and ovary in which cancer rates increase much later in life Cervical cancer mortality reduced dramatically including in young women following the introduction of widespread screening starting in women in their 20s This was aided by the identification of key risk factors sexual activity and HPV infection direct access to the cervical epithelium and an identifiable premalignant stage In contrast in the UK a strong family history FH of BC is the only trigger for BC risk assessment and the opportunity for women aged under 50 to access genetic testing enhanced screening and primary prevention programmes NICE 2013 However in women diagnosed with breast cancer under the age of 40 at least 65 do not have a FH the proportion increasing further in those diagnosed in older age cohorts Copson 2018 Eccles 2015
In addition BC in young women is more frequently lethal due to a combination of later stage at presentation due in part to the lack of screening programmes and a greater proportion of women developing more aggressive BC subtypes Colleoni 2002 Paik 2006 The reliance on FH belies the progress over recent decades in the identification of additional BC risk factors including those related to reproductivelifestyle influences polygenic risk scores PRS and mammographic density MD and their incorporation into robust risk prediction algorithms
The Predicting Risk Of Cancer At Screening PROCAS NIHR Ref RP-PG-0707-10031 study recruited over 58000 women aged 47-73y from the Greater Manchester National Health Service Breast Screening Programme NHSBSP and showed that it is possible to accurately estimate a womans individual risk of developing BC through self-report questions and assessment of MD and PRS van Veen 2018 Using FH alone only 37 of women were identified as being at moderate to high risk of BC according to NICE guidelines NICE 2017 whereas the comprehensive approach above classified 18 as at least moderate risk and with excellent calibration observed to expected OR 098 95CI 069-128 van Veen 2018 At least 30 of the BCs across the whole population developed in this cohort a value that exceeded 40 when additional validated single nucleotide polymorphisms SNPs were incorporated into the PRS Brentnall 2020 Women in the moderatehigh risk groups can then be offered enhanced screening with predicted improvements in survival Evans 2014 and preventive medications that result in fewer BC and are cost saving to the NHS NICE 2017 A follow-on study has been developed to assess the feasibility and acceptability of integrating this approach into the NHSBSP French 2020
The current study has been designed to test whether a similar approach is acceptable in women aged 30-39 years and through use of a case control design will assess the impact of mammographic density on BC risk in women of this age To facilitate the approach we have developed a web-based application WBA based on the Tyrer-Cuzick T-C algorithm see section 12 below and an Automated Low Dose Risk Assessment Mammography ALDRAM technique
The reasons for this dramatic increase in incidence in young women are not well understood and contrast with other endocrine sensitive organs endometrium and ovary in which cancer rates increase much later in life Cervical cancer mortality reduced dramatically including in young women following the introduction of widespread screening starting in women in their 20s This was aided by the identification of key risk factors sexual activity and HPV infection direct access to the cervical epithelium and an identifiable premalignant stage In contrast in the UK a strong family history FH of BC is the only trigger for BC risk assessment and the opportunity for women aged under 50 to access genetic testing enhanced screening and primary prevention programmes NICE 2013 However in women diagnosed with breast cancer under the age of 40 at least 65 do not have a FH the proportion increasing further in those diagnosed in older age cohorts Copson 2018 Eccles 2015
In addition BC in young women is more frequently lethal due to a combination of later stage at presentation due in part to the lack of screening programmes and a greater proportion of women developing more aggressive BC subtypes Colleoni 2002 Paik 2006 The reliance on FH belies the progress over recent decades in the identification of additional BC risk factors including those related to reproductivelifestyle influences polygenic risk scores PRS and mammographic density MD and their incorporation into robust risk prediction algorithms
The Predicting Risk Of Cancer At Screening PROCAS NIHR Ref RP-PG-0707-10031 study recruited over 58000 women aged 47-73y from the Greater Manchester National Health Service Breast Screening Programme NHSBSP and showed that it is possible to accurately estimate a womans individual risk of developing BC through self-report questions and assessment of MD and PRS van Veen 2018 Using FH alone only 37 of women were identified as being at moderate to high risk of BC according to NICE guidelines NICE 2017 whereas the comprehensive approach above classified 18 as at least moderate risk and with excellent calibration observed to expected OR 098 95CI 069-128 van Veen 2018 At least 30 of the BCs across the whole population developed in this cohort a value that exceeded 40 when additional validated single nucleotide polymorphisms SNPs were incorporated into the PRS Brentnall 2020 Women in the moderatehigh risk groups can then be offered enhanced screening with predicted improvements in survival Evans 2014 and preventive medications that result in fewer BC and are cost saving to the NHS NICE 2017 A follow-on study has been developed to assess the feasibility and acceptability of integrating this approach into the NHSBSP French 2020
The current study has been designed to test whether a similar approach is acceptable in women aged 30-39 years and through use of a case control design will assess the impact of mammographic density on BC risk in women of this age To facilitate the approach we have developed a web-based application WBA based on the Tyrer-Cuzick T-C algorithm see section 12 below and an Automated Low Dose Risk Assessment Mammography ALDRAM technique
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None