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| Sponsor: | M.D. Anderson Cancer Center |
|---|---|
| Information provided by: | 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 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.
| Condition | Intervention |
|---|---|
|
Breast Cancer |
Other: Interview Procedure: Blood and Tissue Collection |
| Study Type: | Observational |
| Study Design: | Case Control, Prospective |
| Official Title: | Inflammatory Breast Cancer (IBC) Registry |
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 |
|---|---|
|
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:
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.
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.
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:
1) Secondary IBC
Contacts and Locations| Contact: Massimo Cristofanilli, MD | 713-792-2360 |
| 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 | |
| Principal Investigator: | Massimo Cristofanilli, MD | U.T.M.D. Anderson Cancer Center |
More Information
| 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 4, 2009 |
| ClinicalTrials.gov Identifier: | NCT00477100 History of Changes |
| Health Authority: | United States: Institutional Review Board |
|
Inflammatory Breast Cancer Cancer Registry Core Biopsy Skin Biopsy IBC |
|
Neoplasms Neoplasms by Site Skin Diseases Breast Neoplasms Breast Diseases |