A Multi-Modality Surveillance Program for Women at High Risk for Breast Cancer
- Interventional
- Recruiting
- NCT03729115
Contact Information
Chicago Alternate Prevention Study 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
25 Years and up
Accepting Healthy Volunteers?
Accepts 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.
- 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.