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Inflammatory Breast Cancer (IBC) Registry
This study is currently recruiting participants.
Verified by M.D. Anderson Cancer Center, September 2008
Sponsored by: M.D. Anderson Cancer Center
Information provided by: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00477100
  Purpose

Primary Objective:

To prospectively collect tissue, serum, plasma, clinical, and imaging data from patients with recently diagnosed inflammatory breast cancer (IBC).


Condition Intervention
Breast Cancer
Other: Interview
Procedure: Blood and Tissue Collection

Genetics Home Reference related topics: breast cancer
MedlinePlus related topics: Breast Cancer Cancer
U.S. FDA Resources
Study Type: Observational
Study Design: Case Control, Prospective
Official Title: Inflammatory Breast Cancer (IBC) Registry

Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • To collect blood and tissue samples and clinical data from patients with untreated newly diagnosed 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. [ Time Frame: 6 Years ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

Biospecimen Description:

The collection of serum and plasma from patients with inflammatory breast cancer.


Estimated Enrollment: 200
Study Start Date: April 2007
Estimated Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
1
Patients with recently diagnosed with inflammatory breast cancer (IBC) and have not received any treatment at this time.
Other: Interview
Interview
Procedure: Blood and Tissue Collection
For this study, additional blood (about 4 tablespoons)collected during a routine blood draw, additional 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.

Detailed 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

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 additional breast tissue collected at the time of your standard diagnostic procedure.
  • You will have a core and a skin biopsy. To perform a core and a 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 20 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.

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 200 patients will take part in this study. Up to 150 will be enrolled at M.D. Anderson.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Patients with recently diagnosed inflammatory breast cancer (IBC).

Criteria

Inclusion:

  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:

1. Secondary IBC

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00477100

Contacts
Contact: Massimo Cristofanilli, MD 713-792-2360

Locations
United States, New Mexico
University of New Mexico Recruiting
Albuquerque, New Mexico, United States, 87131
Contact: Melanie Royce, MD, PhD            
United States, Texas
U.T.M.D. Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Principal Investigator: Massimo Cristofanilli, MD            
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
Principal Investigator: Massimo Cristofanilli, MD U.T.M.D. Anderson Cancer Center
  More Information

MD Anderson Cancer Center website  This link exits the ClinicalTrials.gov site

Responsible Party: U.T. M.D. Anderson Cancer Center ( Massimo Cristofanilli, MD/Assoc. Professor )
Study ID Numbers: 2006-1072
Study First Received: May 18, 2007
Last Updated: September 29, 2008
ClinicalTrials.gov Identifier: NCT00477100  
Health Authority: United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:
Inflammatory Breast Cancer
Cancer Registry
Core Biopsy
Skin Biopsy
IBC

Study placed in the following topic categories:
Inflammatory breast cancer
Skin Diseases
Breast Neoplasms
Breast Diseases

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on January 16, 2009