Clinical trial NCT00472589: A Biological Sample Collection Protocol of Women With and Without Breast Cancer
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 type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Lead sponsor: Hoosier Cancer Research Network
Sponsor class: OTHER
Collaborators: name: Purdue University
name: Indiana University School of Medicine
First posted: 2007-05-11
Enrollment: 400
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy women and women with breast cancer

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.

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).
* 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.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Galesburg
country: United States
facility: Medical & Surgical Specialists, LLC
state: Illinois
city: Bloomington
country: United States
facility: Cancer Care Center of Southern Indiana
state: Indiana
city: Evansville
country: United States
facility: Oncology Hematology Associates of SW Indiana
state: Indiana
city: Fort Wayne
country: United States
facility: Fort Wayne Oncology & Hematology, Inc
state: Indiana
city: Indianapolis
country: United States
facility: Indiana University Cancer Center
state: Indiana
city: Indianapolis
country: United States
facility: Quality Cancer Center (MCGOP)
state: Indiana
city: Lafayette
country: United States
facility: Arnett Cancer Care
state: Indiana
city: Lafayette
country: United States
facility: Horizon Oncology Center
state: Indiana
city: Muncie
country: United States
facility: Medical Consultants, P.C.
state: Indiana
city: South Bend
country: United States
facility: Northern Indiana Cancer Research Consortium
state: Indiana
city: Cincinnati
country: United States
facility: Oncology Partners Network
state: Ohio
Study officials:
affiliation: Hoosier Oncology Group, LLC
name: Bryan Schneider, M.D.
role: STUDY_CHAIR
affiliation: Purdue University
name: Fred Regnier
role: PRINCIPAL_INVESTIGATOR
References: