A Multi-Modality Surveillance Program for Women at High Risk for Breast Cancer
ConditionBreast Cancer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age25+
SponsorUniversity of Chicago
About this trial
This study is aimed to establish a registry of women undergoing intensive surveillance for the early detection of breast cancer in high-risk women.
Eligibility criteria
Qualifiers
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.
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.
WISDOM study participant recommended to have MRI every 6 months. OR
Patients with history of chest wall radiation received before age 35. AND
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Magnetic Resonance Imaging (MRI)
Treatment groups
400 Participants
are divided into 1 treatment groupSponsors and collaborators
University of Chicago
Lead sponsor
National Cancer Institute (NCI)
Collaborator
Source ClinicalTrials.gov