Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

Tracking Information
First Submitted Date  ICMJE October 12, 2018
First Posted Date  ICMJE November 2, 2018
Last Update Posted Date February 21, 2019
Actual Study Start Date  ICMJE February 18, 2019
Estimated Primary Completion Date December 20, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 31, 2018)
  • 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.
  • 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03729115 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 31, 2018)
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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Multi-Modality Surveillance Program for Women at High Risk for Breast Cancer
Official Title  ICMJE Personalized Risk-based Prevention for Diverse Populations of High Risk Women
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Condition  ICMJE Breast Cancer
Intervention  ICMJE
  • 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.
Study Arms  ICMJE Screening Arm
Enrolled patients will undergo Magnetic Resonance Imaging (MRI) every 6 months (2x/year) in addition to an annual screening mammogram.
Interventions:
  • Procedure: Magnetic Resonance Imaging (MRI)
  • Other: Clinical Hypnosis
  • Other: Anxiety Self-management Techniques
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: October 31, 2018)
400
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 20, 2023
Estimated Primary Completion Date December 20, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 21 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Ilona Siljander 773-702-2781 isiljanda@uchicago.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03729115
Other Study ID Numbers  ICMJE IRB18-0970
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of Chicago
Study Sponsor  ICMJE University of Chicago
Collaborators  ICMJE National Institutes of Health (NIH)
Investigators  ICMJE
Principal Investigator: Olufunmilayo I Olopade, MD University of Chicago
PRS Account University of Chicago
Verification Date February 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP