A Biological Sample Collection Protocol of Women With and Without Breast Cancer

A Biological Sample Collection Protocol of Women With and Without Breast Cancer: Hoosier Oncology Group Study BRE06-120 for the Analytical Proteomics Team

The purpose of this trial is to collect plasma, serum, whole blood and tissue samples from women with breast cancer and plasma, serum, whole blood from healthy women, which will be made available to researchers for biomarker analysis.

OUTLINE: This is a multi-center study.

The treatment plan for each breast cancer subject will be determined at the discretion of the treating physician and subject. This protocol does not prescribe any particular standard of care treatment.

There will be no treatment for the healthy volunteers.

Inclusion Criteria:

FOR WOMEN WITH BREAST CANCER

• Histologically or cytologically confirmed invasive malignancy or ductal carcinoma in situ of the breast.
• Preparing to begin a new regimen for breast cancer (adjuvant, locally recurrent, any line metastatic).
• Female.
• Age > 18 years at the time of consent.
• Written informed consent and HIPAA authorization for release of personal health information.

FOR HEALTHY VOLUNTEERS

• No known history of invasive malignancy or ductal carcinoma in situ. Volunteers must not have prior history of malignancy in the past 5 years with the exception of basal cell and squamous cell carcinoma of the skin. Other cancers with low potential for metastasis, such as in situ cancers (e.g., Grade 1, TA TCC (low grade superficial bladder cancer), colonic polyp with focus of adenocarcinoma) can also be enrolled as healthy volunteers.
• Female
• Age > 18 years at the time of consent.
• Written informed consent and HIPAA authorization for release of personal health information.

Exclusion Criteria:

• Females must not be pregnant.