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.

Detailed Description:

IBC:

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:

If you are diagnosed with IBC or the doctor believes that you may have IBC, you will be asked to participate in this IBC registry study. This registry study is to collect data, blood and tissue for future studies.

  • For patients who have never received treatment for IBC or have breast condition which the doctor believes may be IBC : You will have a core, breast tissue, and skin biopsy. If lymph nodes are noticed during the core biopsy, lymph nodes core biopsy or final needle aspiration will be done as well. To perform a core, breast tissue, and skin biopsy, an affected area of skin is numbed with anesthetic, and a small amount of skin tissue is removed with a small knife. This is a fresh sample collected for diagnosis and for the study.
  • You will have additional blood (about 4 tablespoons)drawn for this study, during a routine blood draw. The additional blood will not be drawn if you do not have IBC.
  • For patients who have received treatment for IBC: Your original biopsy specimen will be collected for diagnosis (if needed by your doctor) and for the study.
  • You will have an interview. During this interview, you will be asked questions about your medical history as well as general background information. The interview will be conducted by the study chair or their designee in the examination room and after the meeting with the physician in a private setting. The interview will take about 30 minutes to complete. Language Assistance will be called if a participant is non-English speaking. You do not have to be interviewed if you don't have IBC.
  • Your clinical data will be collected from your medical record, including information about your blood and tumor tissue samples and information from the magnetic resonance imaging (MRI) and positron emission tomography/computed tomography (PET/CT) scans you may have had.
  • Photos of both breasts will be taken if needed.

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 MD 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 MD Anderson, including research involving your samples and information from the IBC tissue bank, must first be approved by the IRB.

If the doctor believes your breast condition may be IBC, but tests showed that this tissue was not for breast cancer or IBC, the tissue samples collected will be stored in the IBC tissue bank and used as a non-cancer or non-IBC control sample (healthy tissue used for comparison) in future studies related to IBC.

This is an investigational study. Up to 700 patients will take part in this study. Up to 500 will be enrolled at MD Anderson.

  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:
Breast Neoplasms
Inflammatory Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on August 20, 2014