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A Multi-Modality Surveillance Program for Women at High Risk for Breast Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03729115
Recruitment Status : Recruiting
First Posted : November 2, 2018
Last Update Posted : February 21, 2019
Sponsor:
Collaborator:
National Institutes of Health (NIH)
Information provided by (Responsible Party):
University of Chicago

Brief Summary:
This study is aimed to establish a registry of women undergoing intensive surveillance for the early detection of breast cancer in high-risk women.

Condition or disease Intervention/treatment Phase
Breast Cancer Procedure: Magnetic Resonance Imaging (MRI) Other: Clinical Hypnosis Other: Anxiety Self-management Techniques Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: Personalized Risk-based Prevention for Diverse Populations of High Risk Women
Actual Study Start Date : February 18, 2019
Estimated Primary Completion Date : December 20, 2021
Estimated Study Completion Date : December 20, 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Screening Arm
Enrolled patients will undergo Magnetic Resonance Imaging (MRI) every 6 months (2x/year) in addition to an annual screening mammogram.
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.




Primary Outcome Measures :
  1. Development of faster MRI protocols for a for a Personalized Risk-based Imaging Surveillance Model (PRISM) 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.

  2. 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.


Secondary Outcome Measures :
  1. 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:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Known BRCA1 or BRCA2, TP53, PALB2 carrier. Women with pathogenic mutations in any other cancer susceptibility genes are eligible only if they also have a high PRS.
  2. With life time risk of 40% or higher, based on Polygenic Risk Score that integrates genetic and non-genetic factors.
  3. Without prior breast cancer.
  4. Must be older than 21 years.
  5. Willing to travel to University of Chicago Medical Center for imaging studies as well as any necessary follow-up procedures.
  6. Be able to give informed consent.

Exclusion Criteria

  1. Active cancer at the time of enrollment.
  2. Current pregnancy or plans for pregnancy within two years of enrollment.
  3. Presence of a pacemaker or any other metallic foreign objects in their body that interferes with an MRI.
  4. Breast surgery within two weeks of study entry.
  5. 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.

Information from the National Library of Medicine

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


Contacts
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Contact: Ilona Siljander 773-702-2781 isiljanda@uchicago.edu

Locations
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United States, Illinois
University Of Chicago Medicine Comprehensive Cancer Center Recruiting
Chicago, Illinois, United States, 60637
Contact: Ilona Siljander    773-702-2781      
Principal Investigator: Olufunmilayo Olopade, MD         
Sponsors and Collaborators
University of Chicago
National Institutes of Health (NIH)
Investigators
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Principal Investigator: Olufunmilayo I Olopade, MD University of Chicago

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Responsible Party: University of Chicago
ClinicalTrials.gov Identifier: NCT03729115     History of Changes
Other Study ID Numbers: IRB18-0970
First Posted: November 2, 2018    Key Record Dates
Last Update Posted: February 21, 2019
Last Verified: February 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases