Combined Breast MRI and Biomarker Strategies in Identifying High-risk Breast Cancer Patients
Combined Breast MRI/Biomarker Strategies to Identify Aggressive Biology
Sponsor: City of Hope Medical Center
This observational or N/A phase trial investigates Healthy Subject and is currently ongoing. City of Hope Medical Center leads this study, which shows 19 recorded versions since 2017 — indicating substantial longitudinal coverage. The change history captured here reflects the iterative nature of clinical trial conduct.
Study Description(click to expand)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.
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.
Status Flow
Change History
19 versions recorded-
Apr 23, 2026 — Present [daily]
Active Not Recruiting
Phase: NA → None
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May 2025 — Apr 2026 [monthly]
Active Not Recruiting NA
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Sep 2024 — May 2025 [monthly]
Active Not Recruiting NA
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Jul 2024 — Sep 2024 [monthly]
Active Not Recruiting NA
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May 2024 — Jul 2024 [monthly]
Active Not Recruiting NA
Status: Recruiting → Active Not Recruiting
▶ Show 14 earlier versions
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Dec 2023 — May 2024 [monthly]
Recruiting NA
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Dec 2022 — Dec 2023 [monthly]
Recruiting NA
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Dec 2021 — Dec 2022 [monthly]
Recruiting NA
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Sep 2021 — Dec 2021 [monthly]
Recruiting NA
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Jan 2021 — Sep 2021 [monthly]
Recruiting NA
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Jul 2020 — Jan 2021 [monthly]
Recruiting NA
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Mar 2020 — Jul 2020 [monthly]
Recruiting NA
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Feb 2019 — Mar 2020 [monthly]
Recruiting NA
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Dec 2018 — Feb 2019 [monthly]
Recruiting NA
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Aug 2018 — Dec 2018 [monthly]
Recruiting NA
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Jun 2018 — Aug 2018 [monthly]
Recruiting NA
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Jan 2018 — Jun 2018 [monthly]
Recruiting NA
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Dec 2017 — Jan 2018 [monthly]
Recruiting NA
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Oct 2017 — Dec 2017 [monthly]
Recruiting NA
First recorded
Eligibility 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.
Contact Information
- City of Hope Medical Center
- National Cancer Institute (NCI)
For direct contact, visit the study record on ClinicalTrials.gov .