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

Breast Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00472589
• Other study ID #: BRE06-120
• Secondary ID: BRE06-120
• Status: Completed
• Phase: N/A
• First received: May 9, 2007
• Last updated: August 22, 2016
• Start date: May 2007
• Est. completion date: August 2008

Study information

• Verified date: August 2016
• Source: Hoosier Cancer Research Network
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 400
• Est. completion date: August 2008
• Est. primary completion date: August 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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 Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Locations

Country	Name	City	State
United States	Cancer Care Center of Southern Indiana	Bloomington	Indiana
United States	Oncology Partners Network	Cincinnati	Ohio
United States	Oncology Hematology Associates of SW Indiana	Evansville	Indiana
United States	Fort Wayne Oncology & Hematology, Inc	Fort Wayne	Indiana
United States	Medical & Surgical Specialists, LLC	Galesburg	Illinois
United States	Indiana University Cancer Center	Indianapolis	Indiana
United States	Quality Cancer Center (MCGOP)	Indianapolis	Indiana
United States	Arnett Cancer Care	Lafayette	Indiana
United States	Horizon Oncology Center	Lafayette	Indiana
United States	Medical Consultants, P.C.	Muncie	Indiana
United States	Northern Indiana Cancer Research Consortium	South Bend	Indiana

Sponsors (3)

Lead Sponsor	Collaborator
Hoosier Cancer Research Network	Indiana University School of Medicine, Purdue University

Country where clinical trial is conducted

United States, 

External Links

•   Hoosier Oncology Group Homepage