A Biological Sample Collection Protocol of Women With and Without Breast Cancer
1 other identifier
observational
400
1 country
11
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started May 2007
11 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2007
CompletedFirst Submitted
Initial submission to the registry
May 9, 2007
CompletedFirst Posted
Study publicly available on registry
May 11, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2008
CompletedAugust 23, 2016
August 1, 2016
1.3 years
May 9, 2007
August 22, 2016
Conditions
Study Arms (2)
1
Healthy women
2
Women with breast cancer
Eligibility Criteria
Healthy women and women with breast cancer
You may qualify if:
- 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.
You may not qualify if:
- Females must not be pregnant.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Hoosier Cancer Research Networklead
- Purdue Universitycollaborator
- Indiana University School of Medicinecollaborator
Study Sites (11)
Medical & Surgical Specialists, LLC
Galesburg, Illinois, 61401, United States
Cancer Care Center of Southern Indiana
Bloomington, Indiana, 47403, United States
Oncology Hematology Associates of SW Indiana
Evansville, Indiana, 47714, United States
Fort Wayne Oncology & Hematology, Inc
Fort Wayne, Indiana, 46815, United States
Indiana University Cancer Center
Indianapolis, Indiana, 46202, United States
Quality Cancer Center (MCGOP)
Indianapolis, Indiana, 46202, United States
Arnett Cancer Care
Lafayette, Indiana, 47904, United States
Horizon Oncology Center
Lafayette, Indiana, 47905, United States
Medical Consultants, P.C.
Muncie, Indiana, 47303, United States
Northern Indiana Cancer Research Consortium
South Bend, Indiana, 46601, United States
Oncology Partners Network
Cincinnati, Ohio, 45247, United States
Related Links
Biospecimen
plasma, serum, whole blood and tissue samples
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Bryan Schneider, M.D.
Hoosier Oncology Group, LLC
- PRINCIPAL INVESTIGATOR
Fred Regnier
Purdue University
Study Design
- Study Type
- observational
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 9, 2007
First Posted
May 11, 2007
Study Start
May 1, 2007
Primary Completion
August 1, 2008
Study Completion
August 1, 2008
Last Updated
August 23, 2016
Record last verified: 2016-08