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

Primary Purpose

Breast Cancer

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Magnetic Resonance Imaging (MRI)
Sponsored by
University of Chicago
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Breast Cancer

Eligibility Criteria

25 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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.
  • 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.

Sites / Locations

  • University Of Chicago Medicine Comprehensive Cancer CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Screening Arm

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
October 12, 2018
Last Updated
August 1, 2023
Sponsor
University of Chicago
Collaborators
National Institutes of Health (NIH)
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1. Study Identification

Unique Protocol Identification Number
NCT03729115
Brief Title
A Multi-Modality Surveillance Program for Women at High Risk for Breast Cancer
Acronym
CAPS
Official Title
Chicago Alternative Prevention Study for Diverse Populations of High Risk Women
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 30, 2019 (Actual)
Primary Completion Date
December 31, 2028 (Anticipated)
Study Completion Date
December 31, 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Chicago
Collaborators
National Institutes of Health (NIH)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
400 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Screening Arm
Arm Type
Other
Arm Description
Enrolled patients will undergo Magnetic Resonance Imaging (MRI) every 6 months (2x/year) in addition to an annual screening mammogram.
Intervention Type
Procedure
Intervention Name(s)
Magnetic Resonance Imaging (MRI)
Intervention Description
Patients will have MRI scans every 6 months.
Primary Outcome Measure Information:
Title
Development of faster MRI protocols for a for a Personalized Risk-based Imaging Surveillance Model for diverse populations of high risk women.
Description
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.
Time Frame
5 years

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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. Patients with prior history of breast or ovarian cancer are eligible if they have completed all active treatments and are cancer free for two years. 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 Women can be taking hormone replacement therapy, tamoxifen, raloxifene, aromatase inhibitors, Parp Inhibitors as adjuvant therapy or participating in a chemoprevention trial.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Cancer Clinical Intake Office
Phone
1-855-702-8222
Email
cancerclinicaltrials@bsd.uchicago.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Olufunmilayo I Olopade, MD
Organizational Affiliation
University of Chicago
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Of Chicago Medicine Comprehensive Cancer Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cancer Clinical Trials Intake
Phone
855-702-8222
Email
cancerclinicaltrials@bsd.uchicago.edu
First Name & Middle Initial & Last Name & Degree
Olufunmilayo Olopade, MD

12. IPD Sharing Statement

Learn more about this trial

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

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