Inflammatory Breast Cancer (IBC) Registry
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00477100 |
Recruitment Status
:
Recruiting
First Posted
: May 22, 2007
Last Update Posted
: March 7, 2018
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The goal of this research study is to collect blood and tissue samples and clinical data from patients with inflammatory breast cancer (IBC) or highly suspicious for 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.
This is an investigational study. Up to 1200 patients will take part in this study. Up to 1000 will be enrolled at MD Anderson.
Condition or disease | Intervention/treatment |
---|---|
Breast Cancer | Other: Interview Procedure: Blood and Tissue Collection |

Study Type : | Observational |
Estimated Enrollment : | 1200 participants |
Observational Model: | Case-Control |
Time Perspective: | Prospective |
Official Title: | Inflammatory Breast Cancer (IBC) Registry |
Actual Study Start Date : | April 2007 |
Estimated Primary Completion Date : | April 2020 |
Estimated Study Completion Date : | April 2021 |

Group/Cohort | Intervention/treatment |
---|---|
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.
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- Number of patients with untreated newly diagnosed IBC participating in Registry [ Time Frame: 6 Years ]
Biospecimen Retention: Samples Without DNA

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Probability Sample |
Inclusion Criteria:
- Patients with new clinical diagnosis of primary inflammatory breast cancer (IBC), second primary IBC, or highly suspicious for IBC.
- Histological diagnosis of invasive breast cancer, or highly suspicious for IBC but pending breast cancer diagnosis.
- Be either newly diagnosed, or highly suspicious for IBC (MD Anderson patients only) [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 and punch biopsy) and/or from mastectomy (Cohort II-MD Anderson patients only)
- Age > 18 years
- Able to provide informed consent
Exclusion Criteria:

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00477100
Contact: Jie Willey, MSN, BSN | 713-792-3965 |

Principal Investigator: | Naoto Ueno, MD, PHD | M.D. Anderson Cancer Center |
Additional Information:
Responsible Party: | M.D. Anderson Cancer Center |
ClinicalTrials.gov Identifier: | NCT00477100 History of Changes |
Other Study ID Numbers: |
2006-1072 |
First Posted: | May 22, 2007 Key Record Dates |
Last Update Posted: | March 7, 2018 |
Last Verified: | March 2018 |
Studies a U.S. FDA-regulated Drug Product: | No | |
Studies a U.S. FDA-regulated Device Product: | No |
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 |