Inflammatory Breast Cancer (IBC) Registry

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by M.D. Anderson Cancer Center
Sponsor:
Collaborator:
Susan G. Komen Breast Cancer Foundation
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00477100
First received: May 18, 2007
Last updated: July 16, 2014
Last verified: July 2014
  Purpose

The goal of this research study is to collect blood and tissue samples and clinical data from patients with 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.


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

Resource links provided by NLM:


Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • Number of patients with untreated newly diagnosed IBC participating in Registry [ Time Frame: 6 Years ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

The collection of serum and plasma from patients with inflammatory breast cancer.


Estimated Enrollment: 500
Study Start Date: April 2007
Estimated Primary Completion Date: April 2016 (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.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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 (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, punch biopsy or lymph node biopsy (Cohort II).
  4. Age > 18 years
  5. Able to provide informed consent

Exclusion Criteria:

1) Have had mastectomy/axillary dissection for primary or secondary IBC without core biopsy performed at initial diagnosis.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00477100

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

  Show 20 Study Locations
Sponsors and Collaborators
M.D. Anderson Cancer Center
Susan G. Komen Breast Cancer Foundation
Investigators
Principal Investigator: Naoto Ueno, MD, PHD UT MD Anderson Cancer Center
  More Information

Additional Information:
No publications provided

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: July 16, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:
Inflammatory Breast Cancer
Cancer Registry
Core Biopsy
Skin Biopsy
IBC

Additional relevant MeSH terms:
Inflammatory Breast Neoplasms
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on October 19, 2014