Clinical Trials

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).
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  • 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.