Breast cancer risk assessment for women aged 30-39
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
This study is trying to create a better way to understand breast cancer risk for women aged 30-39 by looking at factors like mammogram results and DNA, to help with early detection and prevention.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1000 (estimated) |
| Ages | 30 Years to 39 Years |
| Sex | Female |
| Sponsor | Manchester University NHS Foundation Trust Government |
| Drugs / interventions | trastuzumab, chemotherapy |
| Locations | 1 site (Manchester, Greater Manchester) |
| Trial ID | NCT05305963 on ClinicalTrials.gov |
What this trial studies
This research aims to develop a comprehensive breast cancer risk assessment strategy specifically for women aged 30-39. It focuses on three main objectives: evaluating the relationship between mammographic density and breast cancer risk, assessing the psychological impact of risk assessment strategies on diverse populations, and exploring DNA methylation signatures from cervical samples to enhance risk prediction models. The study will involve both cases (women diagnosed with breast cancer) and controls (women without a diagnosis) to gather data on risk factors and outcomes. By understanding these elements, the study seeks to improve early detection and prevention strategies for breast cancer in younger women.
Who should consider this trial
Good fit: Ideal candidates for this study are women aged 30-39 who are either diagnosed with breast cancer or are healthy controls within the same age range.
Not a fit: Patients outside the age range of 30-39 or those who have already received systemic therapy for breast cancer may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved risk assessment and early detection strategies for breast cancer in younger women, potentially saving lives.
How similar studies have performed: While there have been studies focusing on breast cancer risk assessment, this specific approach targeting younger women and incorporating diverse methodologies is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
4.1 Inclusion Criteria 4.1.1 Main study The following criteria must be met for entry to the main case control study: 4.1.1.1 Cases * Born biologically female * Aged 30-39 years when diagnosed with breast cancer * Able to provide informed consent 4.1.1.2 Controls * Born biologically female * Aged 30-39 years * Able to provide informed consent 4.1.2 Acceptability Substudy All control participants that are eligible for the main study are eligible for inclusion in the acceptability substudy. 4.1.3 DNA methylation substudy Case participants will only be eligible for the DNAme substudy if they fulfill all eligibility criteria for the main study and the following inclusion criterion: • 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.
Where this trial is running
Manchester, Greater Manchester
- Wythenshawe Hospital — Manchester, Greater Manchester, United Kingdom (Recruiting)
Study contacts
- Study coordinator: Stephanie Ng
- Email: stephanie.ng@manchester.ac.uk
- Phone: 0161 291 4408
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.