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

August 22, 2016 updated by: Hoosier Cancer Research Network

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

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.

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

400

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Galesburg, Illinois, United States, 61401
        • Medical & Surgical Specialists, LLC
    • Indiana
      • Bloomington, Indiana, United States, 47403
        • Cancer Care Center of Southern Indiana
      • Evansville, Indiana, United States, 47714
        • Oncology Hematology Associates of SW Indiana
      • Fort Wayne, Indiana, United States, 46815
        • Fort Wayne Oncology & Hematology, Inc
      • Indianapolis, Indiana, United States, 46202
        • Indiana University Cancer Center
      • Indianapolis, Indiana, United States, 46202
        • Quality Cancer Center (MCGOP)
      • Lafayette, Indiana, United States, 47905
        • Horizon Oncology Center
      • Lafayette, Indiana, United States, 47904
        • Arnett Cancer Care
      • Muncie, Indiana, United States, 47303
        • Medical Consultants, P.C.
      • South Bend, Indiana, United States, 46601
        • Northern Indiana Cancer Research Consortium
    • Ohio
      • Cincinnati, Ohio, United States, 45247
        • Oncology Partners Network

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Healthy women and women with breast cancer

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
1
Healthy women
2
Women with breast cancer

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hoosier Cancer Research Network

Collaborators

Purdue University
Indiana University School of Medicine

Investigators

  • Study Chair: Bryan Schneider, M.D., Hoosier Oncology Group, LLC
  • Principal Investigator: Fred Regnier, Purdue University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2007

Primary Completion (Actual)

August 1, 2008

Study Completion (Actual)

August 1, 2008

Study Registration Dates

First Submitted

May 9, 2007

First Submitted That Met QC Criteria

May 9, 2007

First Posted (Estimate)

May 11, 2007

Study Record Updates

Last Update Posted (Estimate)

August 23, 2016

Last Update Submitted That Met QC Criteria

August 22, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BRE06-120 (Registry Identifier: ClinicalTrials.Gov)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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