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

Hoosier Cancer Research Network

Status: Completed

Conditions: Breast Cancer

Study type: Observational

Funder types: Other

Identifiers

NCT00472589

BRE06-120 (Registry Identifier)

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 400 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts 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.

Trial design

400 participants in 2 patient groups

1

Description:

Healthy women

2

Description:

Women with breast cancer