Inflammatory Breast Cancer (IBC) Registry
Summary
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.
Description
IBC:
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.
Study Participation:
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.
Study Design
Observational Model: Case Control, Time Perspective: Prospective
Conditions
Breast Cancer
Intervention
Interview, Blood and Tissue Collection
Location
City of Hope
Duarte
California
United States
91010
Status
Recruiting
Source
M.D. Anderson Cancer Center
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT00477100
- Information obtained from ClinicalTrials.gov on March 06, 2013
Medical and Biotech [MESH] Definitions
Inflammatory Breast Neoplasms
Metastatic breast cancer characterized by EDEMA and ERYTHEMA of the affected breast due to LYMPHATIC METASTASIS and eventual obstruction of LYMPHATIC VESSELS by the cancer cells.
Fibrocystic Breast Disease
A common and benign breast disease characterized by varying degree of fibrocystic changes in the breast tissue. There are three major patterns of morphological changes, including FIBROSIS, formation of CYSTS, and proliferation of glandular tissue (adenosis). The fibrocystic breast has a dense irregular, lumpy, bumpy consistency.
Biological Specimen Banks
Facilities that collect, store, and distribute tissues, e.g., cell lines, microorganisms, blood, sperm, milk, breast tissue, for use by others. Other uses may include transplantation and comparison of diseased tissues in the identification of cancer.
Carcinoma, Lobular
A infiltrating (invasive) breast cancer, relatively uncommon, accounting for only 5%-10% of breast tumors in most series. It is often an area of ill-defined thickening in the breast, in contrast to the dominant lump characteristic of ductal carcinoma. It is typically composed of small cells in a linear arrangement with a tendency to grow around ducts and lobules. There is likelihood of axillary nodal involvement with metastasis to meningeal and serosal surfaces. (DeVita Jr et al., Cancer: Principles & Practice of Oncology, 3d ed, p1205)
Mucin-1
Carbohydrate antigen elevated in patients with tumors of the breast, ovary, lung, and prostate as well as other disorders. The mucin is expressed normally by most glandular epithelia but shows particularly increased expression in the breast at lactation and in malignancy. It is thus an established serum marker for breast cancer.
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