A Multi-Modality Surveillance Program for Women at High Risk for Breast Cancer (CAPS)
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ClinicalTrials.gov Identifier: NCT03729115 |
Recruitment Status :
Recruiting
First Posted : November 2, 2018
Last Update Posted : May 20, 2020
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Condition or disease | Intervention/treatment | Phase |
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Breast Cancer | Procedure: Magnetic Resonance Imaging (MRI) Other: Clinical Hypnosis Other: Anxiety Self-management Techniques | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 400 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Screening |
Official Title: | Chicago Alternate Prevention Study for Diverse Populations of High Risk Women |
Actual Study Start Date : | February 18, 2019 |
Estimated Primary Completion Date : | December 2021 |
Estimated Study Completion Date : | December 2023 |

Arm | Intervention/treatment |
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Screening Arm
Enrolled patients will undergo Magnetic Resonance Imaging (MRI) every 6 months (2x/year) in addition to an annual screening mammogram.
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Procedure: Magnetic Resonance Imaging (MRI)
Patients will have MRI scans every 6 months. Other: Clinical Hypnosis Patients will provided with an audio recording which includes the technique of Clinical Hypnosis to help manage anxiety during MRI scans. Other: Anxiety Self-management Techniques Participants will be given a workbook with tools and techniques to help manage anxiety and stress related to getting the MRI scans and their overall healthcare. |
- Development of faster MRI protocols for a for a Personalized Risk-based Imaging Surveillance Model for diverse populations of high risk women. [ Time Frame: 5 years ]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.
- Anxiety-reduction in high risk women undergoing MRI using a combination of cognitive-behavioral techniques and clinical hypnosis. [ Time Frame: 5 years ]The cognitive-behavioral anxiety management techniques will be presented in a workbook format and the clinical hypnosis will be presented as an audio recording. Patients will self report their level of anxiety before, during and after MRI.
- Calculation of total healthcare costs for woman under going biannual (2x per year) screening for breast cancer [ Time Frame: 5 years ]Total calculated costs for semi-annual Dynamic Contrast-Enhanced (DCE) MRI screening exams and downstream tests, including diagnostic mammograms, short interval MRI follow-up exams, breast ultrasounds, and breast biopsies will be calculated.

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Ages Eligible for Study: | 25 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Known BRCA1 or BRCA2, TP53, PALB2, PTEN and CDH1 carrier. Women with pathogenic mutations in any other cancer susceptibility genes are eligible only if they also have a high Polygenic Risk Score.
OR With life time risk of 30% or higher, based on Polygenic Risk Score that integrates genetic and non-genetic factors.
- Without prior breast cancer.
- Must be older than 25 years.
- Willing to travel to University of Chicago Medical Center for imaging studies as well as any necessary follow-up procedures.
- Be able to give informed consent.
Exclusion Criteria
- Active cancer 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 objects in their body that interferes with an MRI.
- Breast surgery within two weeks of study entry.
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History of kidney disease or abnormal kidney function.
- Women can be taking hormone replacement therapy, tamoxifen, raloxifene, aromatase inhibitors or participating in a chemoprevention trial.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03729115
Contact: Ian Hurley | 773-702-1973 | hurley@medicine.bsd.uchicago.edu |
United States, Illinois | |
University Of Chicago Medicine Comprehensive Cancer Center | Recruiting |
Chicago, Illinois, United States, 60637 | |
Contact: Ian Hurley 773-702-1973 hurley@medicine.bsd.uchicago.edu | |
Principal Investigator: Olufunmilayo Olopade, MD |
Principal Investigator: | Olufunmilayo I Olopade, MD | University of Chicago |
Responsible Party: | University of Chicago |
ClinicalTrials.gov Identifier: | NCT03729115 |
Other Study ID Numbers: |
IRB18-0970 |
First Posted: | November 2, 2018 Key Record Dates |
Last Update Posted: | May 20, 2020 |
Last Verified: | May 2020 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases |