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| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | May 18, 2007 | ||||
| Last Updated Date | September 4, 2009 | ||||
| Start Date ICMJE | April 2007 | ||||
| Estimated Primary Completion Date | April 2013 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Number of patients with untreated newly diagnosed IBC participating in Registry [ Time Frame: 6 Years ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE |
Prospectively collect tissue, serum, plasma, clinical, and imaging data [ Time Frame: 6 Years ] [ Designated as safety issue: No ] | ||||
| Change History | Complete list of historical versions of study NCT00477100 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | |||||
| Original Secondary Outcome Measures ICMJE | |||||
| Descriptive Information | |||||
| Brief Title ICMJE | Inflammatory Breast Cancer (IBC) Registry | ||||
| Official Title ICMJE | Inflammatory Breast Cancer (IBC) Registry | ||||
| Brief Summary | 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. |
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| Detailed Description | 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. |
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| Study Phase | |||||
| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Case Control Time Perspective: Prospective |
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| Condition ICMJE | Breast Cancer | ||||
| Intervention ICMJE |
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| Study Arms / Comparison Groups | IBC Registry
Blood & Tissue Collection + Interview
Interventions:
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| Publications * | |||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE | 200 | ||||
| Completion Date | |||||
| Estimated Primary Completion Date | April 2013 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria: 1) Secondary IBC |
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00477100 | ||||
| Responsible Party | Massimo Cristofanilli, MD/Assoc. Professor, U.T. M.D. Anderson Cancer Center | ||||
| Study ID Numbers ICMJE | 2006-1072 | ||||
| Study Sponsor ICMJE | M.D. Anderson Cancer Center | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
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| Information Provided By | M.D. Anderson Cancer Center | ||||
| Verification Date | September 2009 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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