Inflammatory Breast Cancer (IBC) Registry
The goal of this research study is to collect blood and tissue samples and clinical data from patients with IBC or highly suspicious for IBC. The blood and tissue samples and clinical data will be stored in a research tissue bank and used to help researchers try to better understand IBC.
|Study Design:||Observational Model: Case Control
Time Perspective: Prospective
|Official Title:||Inflammatory Breast Cancer (IBC) Registry|
- Number of patients with untreated newly diagnosed IBC participating in Registry [ Time Frame: 6 Years ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples Without DNA
The collection of serum and plasma from patients with inflammatory breast cancer.
|Study Start Date:||April 2007|
|Estimated Primary Completion Date:||April 2016 (Final data collection date for primary outcome measure)|
Blood & Tissue Collection + Interview
Personal InterviewProcedure: Blood and Tissue Collection
Blood (about 4 tablespoons) collected during routine blood draw, breast tissue collected at the time of standard diagnostic procedure, and a core and a skin biopsy collected at the time of standard diagnostic procedure.
IBC is a rare but rapidly growing form of breast cancer. Currently, there are no known risk factors and biological features (such as in the genes) that researchers can use to help design better treatments for IBC.
If you are diagnosed with IBC or the doctor believes that you may have IBC, you will be asked to participate in this IBC registry study. This registry study is to collect data, blood and tissue for future studies.
- For patients who have never received treatment for IBC or have breast condition which the doctor believes may be IBC : You will have a core, breast tissue, and skin biopsy. If lymph nodes are noticed during the core biopsy, lymph nodes core biopsy or final needle aspiration will be done as well. To perform a core, breast tissue, and skin biopsy, an affected area of skin is numbed with anesthetic, and a small amount of skin tissue is removed with a small knife. This is a fresh sample collected for diagnosis and for the study.
- You will have additional blood (about 4 tablespoons)drawn for this study, during a routine blood draw. The additional blood will not be drawn if you do not have IBC.
- For patients who have received treatment for IBC: Your original biopsy specimen will be collected for diagnosis (if needed by your doctor) and for the study.
- You will have an interview. During this interview, you will be asked questions about your medical history as well as general background information. The interview will be conducted by the study chair or their designee in the examination room and after the meeting with the physician in a private setting. The interview will take about 30 minutes to complete. Language Assistance will be called if a participant is non-English speaking. You do not have to be interviewed if you don't have IBC.
- Your clinical data will be collected from your medical record, including information about your blood and tumor tissue samples and information from the magnetic resonance imaging (MRI) and positron emission tomography/computed tomography (PET/CT) scans you may have had.
- Photos of both breasts will be taken if needed.
Length of Study:
Your participation in this study will be complete after your samples and data are collected.
Research Tissue Bank:
Before your blood and tissue samples and information can be used for research, the people doing the research must get specific approval from the Institutional Review Board (IRB) of MD Anderson. The IRB is a committee made up of doctors, researchers, and members of the community. The IRB is responsible for protecting the participants involved in research studies and making sure all research is done in a safe and ethical manner. All research done at MD Anderson, including research involving your samples and information from the IBC tissue bank, must first be approved by the IRB.
If the doctor believes your breast condition may be IBC, but tests showed that this tissue was not for breast cancer or IBC, the tissue samples collected will be stored in the IBC tissue bank and used as a non-cancer or non-IBC control sample (healthy tissue used for comparison) in future studies related to IBC.
This is an investigational study. Up to 700 patients will take part in this study. Up to 500 will be enrolled at MD Anderson.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00477100
|Contact: Jie Willey, MSN, BSN||713-792-3965|
Show 20 Study Locations
|Principal Investigator:||Naoto Ueno, MD, PHD||UT MD Anderson Cancer Center|