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Inflammatory Breast Cancer (IBC) Registry
This study is currently recruiting participants.
Verified October 2011 by M.D. Anderson Cancer Center

First Received on May 18, 2007.   Last Updated on October 26, 2011   History of Changes
Sponsor: M.D. Anderson Cancer Center
Information provided by (Responsible Party): M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00477100
  Purpose

The goal of this research study is to collect blood and tissue samples and clinical data from patients with 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.


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

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Inflammatory Breast Cancer (IBC) Registry

Resource links provided by NLM:


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

Primary Outcome Measures:
  • 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.


Estimated Enrollment: 300
Study Start Date: April 2007
Estimated Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
IBC Registry
Blood & Tissue Collection + Interview
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.

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 MD Anderson, or have been treated for IBC and now are seeking further treatment in the IBC clinic at MD 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.
  • For patients who have never received treatment for 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.
  • 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.
  • 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 this bank, must first be approved by the IRB.

This is an investigational study. Up to 450 patients will take part in this study. Up to 300 will be enrolled at MD 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 Criteria:

  1. Patients with new clinical diagnosis of primary inflammatory breast cancer (IBC)
  2. Histological diagnosis of invasive breast cancer
  3. Be either newly diagnosed (Cohort I) or have paraffin blocks or up to 20 unstained slides of each representative block(s) from the time of initial diagnosis of IBC, i.e. core biopsy, punch biopsy or lymph node biopsy (Cohort II-M.D. Anderson patients only)
  4. Age > 18 years
  5. Able to provide informed consent

Exclusion Criteria:

  1. Secondary IBC
  2. Have had mastectomy/axillary dissection for primary IBC.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00477100

Contacts
Contact: Jie Willey, MSN, BSN 713-792-3965

Locations
United States, California
City of Hope Recruiting
Duarte, California, United States, 91010
United States, New Mexico
University of New Mexico Recruiting
Albuquerque, New Mexico, United States, 87131
Contact: Melanie Royce, MD, PhD            
Univeristy of New Mexico Recruiting
Albuquerque, New Mexico, United States, 87131
United States, Texas
U.T.M.D. Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Principal Investigator: Massimo Cristofanilli, MD            
UT Health Science Center - San Antonio Not yet recruiting
San Antonio, Texas, United States, 78229
United States, Wisconsin
Aurora HealthCare Metro Inc. St Luke's Medical Center Not yet recruiting
Milwaukee, Wisconsin, United States, 53215
Brazil
Hospital de Cancer de Barretos-Funcacao Pio XII Not yet recruiting
Sao Paulo, Brazil
Canada, Quebec
McGill University Not yet recruiting
Montreal, Quebec, Canada
France
Institut Paoli Calmettes Not yet recruiting
Marseille, France
Institut Gustave Roussy Not yet recruiting
Villejuif, France
Germany
Univeristy of Tuebingen Not yet recruiting
Tuebingen, Germany
Italy
Azienda Ospedaliero-Universitaria Di Cagliari Not yet recruiting
Cagliari, Italy
Instituti Europeo di Oncologia Not yet recruiting
Milan, Italy
Japan
St. Luke's International Hospital Not yet recruiting
Tokyo, Japan
Mexico
Mexico National Cancer Institute Not yet recruiting
Mexico City, Mexico
Peru
Instituto De Enfermedades Neoplasicas Medical Oncology Not yet recruiting
Lima, Peru
Spain
Hospital Clinico Universitario de Valencia Not yet recruiting
Valencia, Spain
Tunisia
Institute Salah Azaiez Not yet recruiting
Tunis, Tunisia
United Kingdom
UK London Research Institute Not yet recruiting
London, United Kingdom
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
Principal Investigator: Naoto Ueno, MD, PHD UT MD Anderson Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00477100     History of Changes
Other Study ID Numbers: 2006-1072
Study First Received: May 18, 2007
Last Updated: October 26, 2011
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

Additional relevant MeSH terms:
Breast Neoplasms
Inflammatory Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on February 09, 2012