Breast CANcer Risk Assessment in Younger Women: BCAN-RAY

NCT05305963 | Unknown

• 1 other identifier: 309424
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

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

Conditions

Breast Cancer Female

Keywords

Breast; Cervical

Outcome Measures

Primary Outcomes (2)

• 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.

  24 months

• 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

  24 months

Study Arms (2)

Case

250 women diagnosed with BC when they were aged 30-39 years

Radiation: Mammogram

Control

750 controls currently aged 30-39 years

Radiation: Mammogram

Interventions

Mammogram RADIATION

mammogram

Case; Control

Eligibility Criteria

• Age: 30 Years - 39 Years
• Gender Eligibility Details: • Born biologically female for both bcase and control
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

30-39 years for both cases/controls. controls via GP

You may qualify if:

• The following criteria must be met for entry to the main case control study:
• Cases
• Born biologically female
• Aged 30-39 years when diagnosed with breast cancer
• Able to provide informed consent
• Controls
• Born biologically female
• Aged 30-39 years
• Able to provide informed consent
• DNA methylation substudy
• Yet to receive any systemic therapy for early breast cancer (chemotherapy, endocrine therapy or targeted therapy eg trastuzumab (Herceptin))
• All control participants are eligible for the DNAme substudy if eligibility criteria are met for the main study.

Sponsors & Collaborators

• Manchester University NHS Foundation Trust: lead

Study Sites (1)

Wythenshawe Hospital

Manchester, Greater Manchester, M23 9LT, United Kingdom

RECRUITING

Related Publications (1)

• Hindmarch S, Howell SJ, Usher-Smith JA, Gorman L, Evans DG, French DP. Feasibility and acceptability of offering breast cancer risk assessment to general population women aged 30-39 years: a mixed-methods study protocol. BMJ Open. 2024 Jan 10;14(1):e078555. doi: 10.1136/bmjopen-2023-078555.

  PMID: 38199637 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

SNP sample

Central Study Contacts

Stephanie Ng

CONTACT

0161 291 4408; stephanie.ng@manchester.ac.uk

Sacha Howell

CONTACT

01612914408; sacha.howell@nhs.net

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 14, 2022
• First Posted: March 31, 2022
• Study Start: January 31, 2023
• Primary Completion: May 1, 2024
• Study Completion: May 31, 2025
• Last Updated: July 10, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)