Study of Breast Cancer Risk Assessment in Female Patients with Benign Breast Disease
Overview
Tab Title Description
Study type
ObservationalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 75-87
- Jacksonville, Florida: 75-87
Sponsor Protocol Number: 75-87
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
Publications are currently not available