The Mayo Clinic Breast Disease Survivors Study
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: 10-002391
About this study
This study will recruit breast cancer patients and survivors to take part in an ongoing study of the issues and concerns surrounding breast cancer survivorship. We will recruit both newly diagnosed patients as well as patients diagnosed within the past 5 years. Those who consent to the study will be asked to provide a series of questionnaires and blood samples over time. These data/samples will create a repository that will enable us to address many specific hypotheses both now and in the future. As part of the study DNA samples will be genotyped for common genetic variants in an effort to identify common genetic breast cancer risk factors.
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:
- Age 18 years or older.
- Able to provide informed consent.
- Able to reliably complete patient questionnaire.
Cases: All patients who were diagnosed with DCIS, LCIS and all stages of invasive breast cancer and who are in one of the following groups:
- Previously enrolled in “The Epidemiology of Estrogen Genotoxicity and Breast cancer (IRB 244-00) (Defined as part of Group1);
- Previously enrolled in “A Biospecimen Resource for Breast Disease” (IRB 1815-04). (Defined as part of Group1);
- Not enrolled in the two studies above but who were seen at Mayo Clinic since 2004 and are followed by the Mayo Clinic Tumor Registry. (Defined as part of Group 2)
- Women who will be diagnosed, treated, or seen with a new diagnosis (within 12 months) of Breast Cancer (Primary Invasive Breast Cancer, Ductal Carcinoma In Situ (DCIS) or Lobular Carcinoma In Situ (LCIS). (Defined as part of Group 3):
-
- These patients will be identified primarily through physician referral and from the Physician appointment calendars in the Breast Diagnostic clinic (Gonda 2), the Breast Cancer Clinic (Gonda 10) and Medical Oncology (Gonda 10). Other possible sources will be Radiation Oncology, Surgery, Pathology and Tissue Registry;
- Newly diagnosed cases will be contacted at the time of their Mayo Clinic visit and be invited to participate. Those missed at their clinic visit will be mailed a study invitation packet containing the pertinent study materials. Telephone follow-up will be conducted to determine willingness to participate and to arrange the venipuncture or mailing of a blood kit.
Controls: Patients without breast cancer will be included for analysis of breast cancer risk and will come from women who were enrolled as controls in:
- “The Epidemiology of Estrogen Genotoxicity and Breast cancer (IRB 244-00);
- “A Biospecimen Resource for Breast Disease” (IRB 1815-04).
-
- Note: Controls in 1815-04 also include women who were recruited to the Mayo Clinic Biobank, IRB 08-007049 and approved for use as controls in 1815-04.
Tissue Only Controls: Patients who have undergone breast surgery for reduction or other purposes.
Exclusion Criteria:
- Any exceptions to above criteria.
Eligibility last updated 12/8/21. Questions regarding updates should be directed to the study team contact.
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
More information
Publications
Publications are currently not available