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

  • Interventional
  • Recruiting
  • NCT03729115
Eligibility Details Visit Clinicaltrials.gov

Personalized Risk-based Prevention for Diverse Populations of High Risk Women

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

Gender
Female

Age Group
21 Years and up

Accepting Healthy Volunteers?
Accepts Healthy Volunteers

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.

At a Glance

National Government IDNCT03729115

IRB#IRB18-0970

Lead SponsorUniversity of Chicago

Lead PhysicianOlufunmilayo Olopade

Collaborator(s)N/A

EligibilityFemale
21 Years and up
Recruiting