NCT00646555

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2003

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 20, 2003

Completed
4.4 years until next milestone

First Submitted

Initial submission to the registry

March 27, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 28, 2008

Completed
4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 10, 2012

Completed
Last Updated

July 2, 2017

Status Verified

April 10, 2012

First QC Date

March 27, 2008

Last Update Submit

June 30, 2017

Conditions

Keywords

Tissue SamplesVEGF ReceptorsVEGFMicrovessel DensityHypoxia Inducible FactorInflammatory Breast CancerIBC

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with inflammatory breast cancer.
  • Age greater than 18 years.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

GW University Medical Center GW Hospital Center

Washington D.C., District of Columbia, 20037, United States

Location

Related Publications (3)

  • Folkman J. Angiogenesis and apoptosis. Semin Cancer Biol. 2003 Apr;13(2):159-67. doi: 10.1016/s1044-579x(02)00133-5.

    PMID: 12654259BACKGROUND
  • Weidner N, Semple JP, Welch WR, Folkman J. Tumor angiogenesis and metastasis--correlation in invasive breast carcinoma. N Engl J Med. 1991 Jan 3;324(1):1-8. doi: 10.1056/NEJM199101033240101.

    PMID: 1701519BACKGROUND
  • Gasparini G, Weidner N, Bevilacqua P, Maluta S, Dalla Palma P, Caffo O, Barbareschi M, Boracchi P, Marubini E, Pozza F. Tumor microvessel density, p53 expression, tumor size, and peritumoral lymphatic vessel invasion are relevant prognostic markers in node-negative breast carcinoma. J Clin Oncol. 1994 Mar;12(3):454-66. doi: 10.1200/JCO.1994.12.3.454.

    PMID: 7509851BACKGROUND

MeSH Terms

Conditions

Breast NeoplasmsInflammatory Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Amy Subar, Ph.D.

    National Cancer Institute (NCI)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Sponsor Type
NIH

Study Record Dates

First Submitted

March 27, 2008

First Posted

March 28, 2008

Study Start

November 20, 2003

Study Completion

April 10, 2012

Last Updated

July 2, 2017

Record last verified: 2012-04-10

Locations