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| ID | Type | Description | Link |
|---|---|---|---|
| 5R01CA276652 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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This study is aimed to establish a registry of women undergoing intensive surveillance for the early detection of breast cancer in high-risk women.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Screening Arm | Other | Enrolled patients will undergo Magnetic Resonance Imaging (MRI) every 6 months (2x/year) in addition to an annual screening mammogram. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Magnetic Resonance Imaging (MRI) | Procedure | Patients will have MRI scans every 6 months. |
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| Measure | Description | Time Frame |
|---|---|---|
| Development of faster MRI protocols for a for a Personalized Risk-based Imaging Surveillance Model for diverse populations of high risk women. | We will test whether an abbreviated MRI (AB-MRI) is diagnostically equivalent to a full MRI. Eligible women will be scanned every 6 months with a full protocol MRI. | 5 years |
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Inclusion Criteria:
- Known BRCA1 or BRCA2, TP53, PALB2, PTEN, CDH1 and STK11 carrier. Women with pathogenic mutations in any other cancer susceptibility genes are eligible only if they also have a high PRS.
OR
With life time risk of 30% or higher, based on Polygenic Risk Score that integrates genetic and non-genetic factors OR
5-years risk ≥ 6% for women 40-64 OR
5-years risk ≥ 6% for women 65+ AND breast density C or D AND a lifetime risk >= 20% (BCSC+PRS LTR or Tyrer-Cuzick LTR) OR
Patients with history of chest wall radiation received before age 35. OR
To promote health equity, women of African Ancestry < 45 years with at least one 1st or 2nd degree relative with breast or ovarian cancer are eligible because PRS Scores are not currently reported for AA women.
Must be at least 25 years old.
Willing to travel to participating site for imaging studies as well as any necessary follow-up procedures.
Be able to give informed consent.
Exclusion Criteria
Undergoing active cancer treatment at the time of enrollment.
Current pregnancy or plans for pregnancy within two years of enrollment.
Presence of a pacemaker or any other metallic foreign object in their body that interferes with an MRI.
Breast surgery within two weeks of study entry.
Women with history of bilateral mastectomy are not eligible
History of kidney disease or abnormal kidney function.
History of dye allergy unless it can be mediated with antihistamines and/or steroids
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Cancer Clinical Intake Office | Contact | 1-855-702-8222 | cancerclinicaltrials@bsd.uchicago.edu |
| Name | Affiliation | Role |
|---|---|---|
| Olufunmilayo I Olopade, MD | University of Chicago | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Of Chicago Medicine Comprehensive Cancer Center | Recruiting | Chicago | Illinois | 60637 | United States |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| D009682 | Magnetic Resonance Spectroscopy |
| ID | Term |
|---|---|
| D013057 | Spectrum Analysis |
| D002623 | Chemistry Techniques, Analytical |
| D008919 | Investigative Techniques |
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| D017437 |
| Skin and Connective Tissue Diseases |