Status:
COMPLETED
A Biological Sample Collection Protocol of Women With and Without Breast Cancer
Lead Sponsor:
Hoosier Cancer Research Network
Collaborating Sponsors:
Purdue University
Indiana University School of Medicine
Conditions:
Breast Cancer
Eligibility:
FEMALE
18+ years
Brief Summary
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 r...
Detailed 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 a...
Eligibility Criteria
Inclusion
- 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
- Females must not be pregnant.
Key Trial Info
Start Date :
May 1 2007
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
August 1 2008
Estimated Enrollment :
400 Patients enrolled
Trial Details
Trial ID
NCT00472589
Start Date
May 1 2007
End Date
August 1 2008
Last Update
August 23 2016
Active Locations (11)
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1
Medical & Surgical Specialists, LLC
Galesburg, Illinois, United States, 61401
2
Cancer Care Center of Southern Indiana
Bloomington, Indiana, United States, 47403
3
Oncology Hematology Associates of SW Indiana
Evansville, Indiana, United States, 47714
4
Fort Wayne Oncology & Hematology, Inc
Fort Wayne, Indiana, United States, 46815