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Inflammatory Breast Cancer (IBC) Registry

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ClinicalTrials.gov Identifier: NCT00477100
Recruitment Status : Recruiting
First Posted : May 22, 2007
Last Update Posted : March 7, 2018
Sponsor:
Collaborator:
Susan G. Komen Breast Cancer Foundation
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Study Description
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:

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

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Study Design
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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
U.S. FDA Resources

Groups and Cohorts
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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.


Outcome Measures
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Primary Outcome Measures :
  1. Number of patients with untreated newly diagnosed IBC participating in Registry [ Time Frame: 6 Years ]

Biospecimen Retention:   Samples Without DNA
The collection of serum and plasma from patients with inflammatory breast cancer.

Eligibility Criteria
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Information from the National Library of Medicine

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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
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), second primary IBC, or highly suspicious for IBC.
  2. Histological diagnosis of invasive breast cancer, or highly suspicious for IBC but pending breast cancer diagnosis.
  3. 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)
  4. Age > 18 years
  5. Able to provide informed consent

Exclusion Criteria:

Contacts and Locations
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Information from the National Library of Medicine

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


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

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Sponsors and Collaborators
M.D. Anderson Cancer Center
Susan G. Komen Breast Cancer Foundation
Investigators
Principal Investigator: Naoto Ueno, MD, PHD M.D. Anderson Cancer Center
More Information
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Additional Information:
University of Texas MD Anderson Cancer Center Website  This link exits the ClinicalTrials.gov site

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