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


N/A
18 Years
N/A
Not Enrolling
Female
Breast Cancer

Thank you

Trial Information

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


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.

Type of Study:

Observational

Study Design:

Time Perspective: Prospective

Principal Investigator

Bryan Schneider, M.D.

Investigator Role:

Study Chair

Investigator Affiliation:

Hoosier Oncology Group, LLC

Authority:

United States: Institutional Review Board

Study ID:

BRE06-120

NCT ID:

NCT00472589

Start Date:

May 2007

Completion Date:

August 2008

Related Keywords:

  • Breast Cancer
  • Breast Neoplasms

Name

Location

Indiana University Cancer CenterIndianapolis, Indiana  46202-5265
Oncology Partners NetworkCincinnati, Ohio  45238
Arnett Cancer CareLafayette, Indiana  47904
Northern Indiana Cancer Research ConsortiumSouth Bend, Indiana  
Medical & Surgical Specialists, LLCGalesburg, Illinois  61401
Cancer Care Center Of Southern IndianaBloomington, Indiana  47403
Horizon Oncology CenterLafayette, Indiana  47905
Oncology Hematology Associates of SW IndianaEvansville, Indiana  47714
Quality Cancer Center (MCGOP)Indianapolis, Indiana  46202
Medical Consultants, P.C.Muncie, Indiana  47303
Fort Wayne Oncology & Hematology, IncFort Wayne, Indiana  46815