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| 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 |
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.
|
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.
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 |
Patients with recently diagnosed inflammatory breast cancer (IBC).
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Jie Willey, MSN, BSN | 713-792-3965 |
| 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 | |
| Principal Investigator: | Naoto Ueno, MD, PHD | UT MD Anderson Cancer Center |
More Information
| 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 |
|
Inflammatory Breast Cancer Cancer Registry Core Biopsy Skin Biopsy IBC |
|
Breast Neoplasms Inflammatory Breast Neoplasms Neoplasms by Site |
Neoplasms Breast Diseases Skin Diseases |