A Multi-Modality Surveillance Program for Women at High Risk for Breast Cancer
University of Chicago · with National Cancer Institute (NCI) · NCT03729115
Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.
Key facts
- Compensation
- Not posted. Ask the study team before screening.
- Who can join
- Ages 25+ · Women only
- Healthy volunteers
- Accepted
- Study type
- Interventional · Not applicable
- Target enrollment
- 400
- US sites recruiting
- 3
- Study start
- May 30, 2019
- Record last updated
- September 1, 2026
Status re-checked against ClinicalTrials.gov within the last 12 hours.
What the study is about
This study is aimed to establish a registry of women undergoing intensive surveillance for the early detection of breast cancer in high-risk women.
Being studied: Magnetic Resonance Imaging (MRI)
Conditions: Breast Cancer
Eligibility criteria
Copied from the official record. The study team makes the final decision at screening.
Show full criteria
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.
Recruiting US locations
University of California, San Diego
La Jolla, CA 92093
Site contact: Lorena Pineda · 858-534-2010 · lopineda@health.ucsd.edu
University of California, Davis
Sacramento, CA 95817
Site contact: Genella Cipar · 916-734-9004 · research-radiology-som@health.ucdavis.edu
University Of Chicago Medicine Comprehensive Cancer Center
Chicago, IL 60637
Site contact: Cancer Clinical Trials Intake · 855-702-8222 · cancerclinicaltrials@bsd.uchicago.edu
Study contacts (from the official record)
- Cancer Clinical Intake Office · 1-855-702-8222 · cancerclinicaltrials@bsd.uchicago.edu
Similar studies in California
All healthy volunteers studies in California →- RecruitingHealthy volunteersPhase 1Overnight stay mentioned
A Study to Investigate the Relative Bioavailability and Safety of Different Oral Formulations of Elecoglipron in Healthy Participants
AstraZeneca
- Location
- Glendale, CA + 1 other US site
- Eligibility basics
- Ages 18–55
- RecruitingHealthy volunteersPhase 1Overnight stay mentioned
A Phase I Study to Investigate the Pharmacokinetics and Safety of Capivasertib in Participants With Moderate Hepatic Impairment
AstraZeneca
- Location
- Rialto, CA + 1 other US site
- Eligibility basics
- Ages 18–80
- RecruitingHealthy volunteersPhase 1Overnight stay mentioned
A Study to Learn How the Body Processes the Study Medicine PF-07328948 in People With Reduced Kidney Function
Pfizer
- Location
- Lake Forest, CA + 3 other US sites
- Eligibility basics
- Ages 18–80
- RecruitingHealthy volunteersPhase 1Overnight stay mentioned
Phase 1 Study of SBS-147 in Healthy Adults
Sparian Biosciences, Inc
- Location
- Cypress, CA
- Eligibility basics
- Ages 18–55