Study of Breast Cancer Risk Assessment in Female Patients with Benign Breast Disease


About this study

The purpose of this study is to to bring molecular risk prediction for breast cancer into the clinical arena through: the establishment of a large tissue repository from a retrospective cohort of women with benign breast disease with complete and long-term clinical follow-up to identify those who developed breast cancer (cases) and those who did not (controls); the application of potential biomarkers of risk to this archival tissue set; and, the discovery of new, potentially relevant biomarkers of risk in fresh and frozen specimens of benign breast disease. 

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

  • All female patients, ages 18 to 100 years.
  • Had a breast biopsy at Mayo Clinic between 1/1/67 and 3/31/2020 with benign findings.

Exclusion Criteria:

  • All male patients.
  • Prior or concomitant diagnosis of breast cancer.
  • Diagnosis of breast cancer within six months of benign breast disease.
  • Denial of research authorization.
  • Concurrent or post-biopsy prophylactic mastectomy.
  • Women who had a tissue examined subsequent to reduction mammoplasty or implant related surgery

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Amy Degnim, M.D.

Open for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

Jacksonville, Fla.

Mayo Clinic principal investigator

Mark Sherman, M.D.

Contact us for the latest status

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

More information


Publications are currently not available

Additional contact information

Cancer-related trials contact form

Phone: 855-776-0015 (toll-free)

International patient clinical studies questions