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Inflammatory Breast Cancer (IBC) Registry
This study is currently recruiting participants.
Study NCT00477100   Information provided by M.D. Anderson Cancer Center
First Received: May 18, 2007   Last Updated: September 4, 2009   History of Changes

May 18, 2007
September 4, 2009
April 2007
April 2013   (final data collection date for primary outcome measure)
Number of patients with untreated newly diagnosed IBC participating in Registry [ Time Frame: 6 Years ] [ Designated as safety issue: No ]
Prospectively collect tissue, serum, plasma, clinical, and imaging data [ Time Frame: 6 Years ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00477100 on ClinicalTrials.gov Archive Site
 
 
 
Inflammatory Breast Cancer (IBC) Registry
Inflammatory Breast Cancer (IBC) Registry

The goal of this research study is to collect blood and tissue samples and clinical data from patients with untreated newly diagnosed inflammatory breast cancer (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.

IBC:

Inflammatory breast cancer (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:

Participants in this study will be identified at the time of their first visit to M. D. Anderson. If you agree to take part in this study, you will have the following tests/procedures performed.

  • You will have additional blood (about 4 tablespoons) drawn for this study, during a routine blood draw.
  • 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 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.
  • 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.

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 M. D. 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 M. D. Anderson, including research involving your samples and information from this bank, must first be approved by the IRB.

This is an investigational study. Up to 300 patients will take part in this study. Up to 150 will be enrolled at M.D. Anderson.

 
Observational
Observational Model:  Case Control
Time Perspective:  Prospective
Breast Cancer
  • Other: Interview
    Personal Interview
  • Procedure: 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 Registry
Blood & Tissue Collection + Interview
Interventions:
  • Other: Interview
  • Procedure: Blood and Tissue Collection
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Recruiting
200
 
April 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Patients with new clinical diagnosis of primary inflammatory breast cancer (IBC)
  2. Histological diagnosis of invasive breast cancer
  3. No previous or current treatment for newly diagnosed IBC
  4. Age > 18 years
  5. Able to provide informed consent

Exclusion Criteria:

1) Secondary IBC

Both
18 Years and older
No
Contact: Massimo Cristofanilli, MD 713-792-2360
United States
 
NCT00477100
Massimo Cristofanilli, MD/Assoc. Professor, U.T. M.D. Anderson Cancer Center
2006-1072
M.D. Anderson Cancer Center
 
Principal Investigator: Massimo Cristofanilli, MD M.D. Anderson Cancer Center
M.D. Anderson Cancer Center
September 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP