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Clinical Trials/NCT00472589
NCT00472589
Completed
Not Applicable

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

Hoosier Cancer Research Network11 sites in 1 country400 target enrollmentMay 2007
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ConditionsBreast Cancer

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Breast Cancer
Sponsor
Hoosier Cancer Research Network
Enrollment
400
Locations
11
Status
Completed
Last Updated
9 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

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 researchers for biomarker analysis.

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 any particular standard of care treatment. There will be no treatment for the healthy volunteers.

Registry
clinicaltrials.gov
Start Date
May 2007
End Date
August 2008
Last Updated
9 years ago
Study Type
Observational
Sex
Female

Investigators

Sponsor
Hoosier Cancer Research Network
Responsible Party
Sponsor

Eligibility Criteria

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).
  • •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.
  • •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.

Outcomes

Primary Outcomes

Not specified

Study Sites (11)

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