deltatrials
Active Not Recruiting INTERVENTIONAL NCT03303846

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

Updated 19 times since 2017 Last updated: Apr 20, 2026 Started: Oct 13, 2017 Primary completion: Nov 20, 2026 Completion: Nov 20, 2026
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

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

~Oct 2017 – ~Dec 2017 · 2 months · monthly snapshot~Dec 2017 – ~Jan 2018 · 31 days · monthly snapshot~Jan 2018 – ~Jun 2018 · 5 months · monthly snapshot~Jun 2018 – ~Aug 2018 · 2 months · monthly snapshot~Aug 2018 – ~Dec 2018 · 4 months · monthly snapshot~Dec 2018 – ~Feb 2019 · 2 months · monthly snapshot~Feb 2019 – ~Mar 2020 · 13 months · monthly snapshot~Mar 2020 – ~Jul 2020 · 4 months · monthly snapshot~Jul 2020 – ~Jan 2021 · 6 months · monthly snapshot~Jan 2021 – ~Sep 2021 · 8 months · monthly snapshot~Sep 2021 – ~Dec 2021 · 3 months · monthly snapshot~Dec 2021 – ~Dec 2022 · 12 months · monthly snapshot~Dec 2022 – ~Dec 2023 · 12 months · monthly snapshot~Dec 2023 – ~May 2024 · 5 months · monthly snapshot~May 2024 – ~Jul 2024 · 2 months · monthly snapshot~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshot~Sep 2024 – ~May 2025 · 8 months · monthly snapshot~May 2025 – ~Apr 2026 · 12 months · monthly snapshotApr 23, 2026 – present · 3 months · daily API

Change History

19 versions recorded
  1. Apr 23, 2026 — Present [daily]

    Active Not Recruiting

    Phase: NANone

  2. May 2025 — Apr 2026 [monthly]

    Active Not Recruiting NA

  3. Sep 2024 — May 2025 [monthly]

    Active Not Recruiting NA

  4. Jul 2024 — Sep 2024 [monthly]

    Active Not Recruiting NA

  5. May 2024 — Jul 2024 [monthly]

    Active Not Recruiting NA

    Status: RecruitingActive Not Recruiting

Show 14 earlier versions
  1. Dec 2023 — May 2024 [monthly]

    Recruiting NA

  2. Dec 2022 — Dec 2023 [monthly]

    Recruiting NA

  3. Dec 2021 — Dec 2022 [monthly]

    Recruiting NA

  4. Sep 2021 — Dec 2021 [monthly]

    Recruiting NA

  5. Jan 2021 — Sep 2021 [monthly]

    Recruiting NA

  6. Jul 2020 — Jan 2021 [monthly]

    Recruiting NA

  7. Mar 2020 — Jul 2020 [monthly]

    Recruiting NA

  8. Feb 2019 — Mar 2020 [monthly]

    Recruiting NA

  9. Dec 2018 — Feb 2019 [monthly]

    Recruiting NA

  10. Aug 2018 — Dec 2018 [monthly]

    Recruiting NA

  11. Jun 2018 — Aug 2018 [monthly]

    Recruiting NA

  12. Jan 2018 — Jun 2018 [monthly]

    Recruiting NA

  13. Dec 2017 — Jan 2018 [monthly]

    Recruiting NA

  14. 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

Sponsor contact:
  • City of Hope Medical Center
  • National Cancer Institute (NCI)
Data source: ClinicalTrials.gov

For direct contact, visit the study record on ClinicalTrials.gov .