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Recruiting

NCT Number: NCT03729115

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

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

Recruiting

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Key information

Age range

25 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University Of Chicago Medicine Comprehensive Cancer Center

Chicago, Illinois, 60637, United States

Location status: Recruiting

Location contact

Cancer Clinical Trials Intake

CONTACT

[email protected]

1-855-702-8222

Olufunmilayo Olopade, MD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Known carrier of PV in BRCA1, BRCA2, TP53, PALB2, PTEN, CDH1 or STK11 gene. Women with PV in any other cancer susceptibility genes are eligible if they also have an estimated lifetime risk of 30% or higher based on the integrated risk score, as described below.

OR

  • Results from a CLIA approved laboratory with estimated lifetime risk of 30% or higher, based on integrated risk score that includes polygenic risk score (PRS) e.g Myriad Model.

OR

  • WISDOM study participant recommended to have MRI every 6 months. OR
  • Patients with history of chest wall radiation received before age 35. AND
  • 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 or any cancer associated with inherited pathogenic mutations in BRCA1/2, PALB2, CDH1, TP53, PTEN or STK11 related mutation are eligible if they meet the inclusion criteria, have completed all active treatments and are cancer free.
  • Willing to travel to the University of Chicago Medicine

Exclusion criteria

  • Undergoing active cancer treatment at the time of enrollment.
  • Current pregnancy.
  • 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.
  • Women who are pregnant can return to the study after pregnancy. Expected timeframe to return back to the study after pregnancy is within 6 months post-delivery.
  • Women can return to the study after being treated for early-stage breast cancer. Timing of return to the study will be per investigator's discretion.

Treatment and study plan

Magnetic Resonance Imaging (MRI)

Procedure

Patients will have MRI scans every 6 months.

Primary outcomes

  1. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Cancer Clinical Intake Office

CONTACT

[email protected]

1-855-702-8222

Sponsors and collaborators

Lead sponsor

University of Chicago

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

Chicago Alternative Prevention Study for BreAst CAncer inHigh Risk Women - CAPSBRACA

Acronym: CAPS

Important dates

Study start
2019
Primary completion
2028
Study completion
2028
First posted
Nov 2, 2018
Registry last updated
Aug 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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