Inflammatory Breast Cancer, Tumor Markers, and Factors Associated With Angiogenesis

June 30, 2017 updated by: National Cancer Institute (NCI)

Evaluation of Angiogenesis Parameters and Tumor Markers in Inflammatory Breast Cancer Specimens

This study, conducted by the NCI and the George Washington University Medical Center (GWUMC), will examine breast tissue from patients with inflammatory breast cancer (IBC) for tumor markers and factors associated with angiogenesis. Angiogenesis is the formation of new blood vessels that is essential for tumor growth and spread. IBC is an extremely rare, aggressive form of breast cancer that disproportionately affects young women. The risk factors for IBC, its cause, and how it develops are unknown, but the disease appears to involve a high degree of angiogenesis.

Tissue specimens for this study will be obtained from GWUMC's Inflammatory Breast Cancer Registry and Biospecimen Repository. The registry was established to develop a national registry of patients with IBC that includes standardized clinical, epidemiological, and pathological information, along with disease recurrence and survival data.

For this study, tissue specimens from the repository will be tested for biological markers and angiogenesis parameters to help in the classification of the tumors. Biological markers (such as estrogen receptor, progesterone receptor, the p53 gene, and others) and angiogenesis parameters (such as various proteins involved in vessel formation) will be examined to determine their prevalence in tissue specimens and their relationship to patient survival. When possible, the findings will be compared with non-IBC tissue samples.

Study Overview

Status

Completed

Conditions

Detailed Description

Inflammatory breast carcinoma (IBC) is an extremely rare, aggressive form of breast cancer that disproportionately affects young women. The risk factors and pathogenesis of these tumors are unknown and it is unclear whether tumors showing various clinical, pathological or molecular features behave differently. IBC appears to be a highly angiogenic tumor. In this study, tumor markers and parameters of angiogenesis will be further investigated in IBC.

The Inflammatory Breast Cancer Registry and Biospecimen Repository is a project funded by a grant from the Department of Defense to Paul H. Levine at GWUMC. The purpose of the registry is to develop a national registry of patients with IBC that will contain standardized clinical, epidemiological, and pathological information, along with recurrence and survival data. The goal is to obtain specimens from approximately 150 patients with IBC. The data in the registry and repository will be made available to researchers to aid in the development of a clinicopathological diagnosis of IBC. Investigators at GWUMC will consent recruited patients and collect clinical data. Subjects will not be recruited, evaluated, or monitored at the NCI. The GWUMC IRB will oversee human subjects protection issues. All samples obtained from GWUMC will be blinded and coded to the NCI investigators. In addition to the samples from George Washington University, we will obtain 150 control samples from the National Cancer Institute Cooperative Breast Cancer Tissue Resource. These samples were not available when this protocol was first submitted.

In collaboration with George Washington University Medical Center (GWUMC), we plan to test tissue specimens collected in the IBC registry and biospecimen repository. We will obtain frozen tissue (tissue and/or normal) and paraffin-embedded tissue blocks from each case. Genetic testing will not be performed on any of the samples. One pathologist reviews cases for grade and lymphovascular invasion (LVI) based on H& E staining. Specimens will be tested for biological markers associated with IBC to help in classification of these tumors. These include ER, E-cadherin, podoplanin, ReIB, RhoC and vasodilator-stimulated phosphoprotein (VASP). Angiogenesis parameters will also be evaluated. These include hypoxia-inducible factor 1 alpha (HIF-1 alpha), vascular endothelial growth factor D (VEGF-D) protein expression, VEGF-C protein expression, VEGF-receptor 2 (VEGFR-2, Kdr) or VEGF-receptor 3 (VEGFR-3, flt-4).

Study Type

Observational

Enrollment (Anticipated)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • District of Columbia
      • Washington, D.C., District of Columbia, United States, 20037
        • GW University Medical Center GW Hospital Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

  • INCLUSION CRITERIA:

Patients with inflammatory breast cancer.

Age greater than 18 years.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Amy Subar, Ph.D., National Cancer Institute (NCI)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 20, 2003

Study Completion

April 10, 2012

Study Registration Dates

First Submitted

March 27, 2008

First Submitted That Met QC Criteria

March 27, 2008

First Posted (Estimate)

March 28, 2008

Study Record Updates

Last Update Posted (Actual)

July 2, 2017

Last Update Submitted That Met QC Criteria

June 30, 2017

Last Verified

April 10, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 999904051
  • 04-C-N051

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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