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

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ClinicalTrials.gov Identifier: NCT00472589
Recruitment Status : Completed
First Posted : May 11, 2007
Last Update Posted : August 23, 2016
Sponsor:
Collaborators:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease
Breast Cancer

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.


Study Design

Study Type : Observational
Actual Enrollment : 400 participants
Time Perspective: Prospective
Official Title: A Biological Sample Collection Protocol of Women With and Without Breast Cancer: Hoosier Oncology Group Study BRE06-120 for the Analytical Proteomics Team
Study Start Date : May 2007
Primary Completion Date : August 2008
Study Completion Date : August 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
U.S. FDA Resources

Groups and Cohorts

Group/Cohort
1
Healthy women
2
Women with breast cancer


Outcome Measures

Biospecimen Retention:   Samples With DNA
plasma, serum, whole blood and tissue samples

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Healthy women and women with breast cancer
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).
  • 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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00472589


Locations
United States, Illinois
Medical & Surgical Specialists, LLC
Galesburg, Illinois, United States, 61401
United States, Indiana
Cancer Care Center of Southern Indiana
Bloomington, Indiana, United States, 47403
Oncology Hematology Associates of SW Indiana
Evansville, Indiana, United States, 47714
Fort Wayne Oncology & Hematology, Inc
Fort Wayne, Indiana, United States, 46815
Indiana University Cancer Center
Indianapolis, Indiana, United States, 46202
Quality Cancer Center (MCGOP)
Indianapolis, Indiana, United States, 46202
Arnett Cancer Care
Lafayette, Indiana, United States, 47904
Horizon Oncology Center
Lafayette, Indiana, United States, 47905
Medical Consultants, P.C.
Muncie, Indiana, United States, 47303
Northern Indiana Cancer Research Consortium
South Bend, Indiana, United States, 46601
United States, Ohio
Oncology Partners Network
Cincinnati, Ohio, United States, 45247
Sponsors and Collaborators
Hoosier Cancer Research Network
Purdue University
Indiana University School of Medicine
Investigators
Study Chair: Bryan Schneider, M.D. Hoosier Oncology Group, LLC
Principal Investigator: Fred Regnier Purdue University
More Information

Additional Information:
Responsible Party: Hoosier Cancer Research Network
ClinicalTrials.gov Identifier: NCT00472589     History of Changes
Other Study ID Numbers: BRE06-120
BRE06-120 ( Registry Identifier: ClinicalTrials.Gov )
First Posted: May 11, 2007    Key Record Dates
Last Update Posted: August 23, 2016
Last Verified: August 2016

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases