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Combined Breast MRI and Biomarker Strategies in Identifying High-risk Breast Cancer Patients

Healthy Subject Clinical Trial

Official title:
Combined Breast MRI/Biomarker Strategies to Identify Aggressive Biology

Clinical Trial Summary

This clinical trial studies normal breast tissue changes combined with breast magnetic resonance imaging (MRI) that may suggest the beginnings of cancer development. Using breast tissue markers in combination with breast imaging such as MRI may help to more accurately assess a woman's risk of developing breast cancer.

Clinical Trial Description

PRIMARY OBJECTIVES: I. To determine the number of high risk women with abnormal screening breast MRI and morphologically normal biopsy over 7 years. SECONDARY OBJECTIVES: I. To determine if WNT10B/mutant p53 expression as measured in the 0-month biopsy predicts women with an abnormal MRI/non-cancerous biopsy who will progress to cancer over 7 years. TERTIARY OBJECTIVES: I. To determine the predictive accuracy of WNT10B with MRI, of which will be compared with MRI alone using the C-index. OUTLINE: Participants undergo standard of care high risk breast cancer screening MRIs at baseline and follow-up and blood sample collection at baseline. Participants undergo collection of breast tissue samples at any breast biopsy or breast surgery. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03303846
Study type Interventional
Source City of Hope Medical Center
Contact
Status Active, not recruiting
Phase N/A
Start date October 13, 2017
Completion date April 25, 2026
View Details
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