Establishing an Inflammatory Breast Cancer Registry

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

164 participants

Study Classification

OBSERVATIONAL

Study Start Date

2003-06-30

Brief Summary

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Inflammatory breast carcinoma (IBC) is an extremely rare, aggressive form of breast cancer that disproportionately impacts young women. IBC often affects the skin of the breast, as well as the breast itself, making it appear inflamed. The purpose of this study is to collect data and information on IBC patients so that researchers can study factors associated with IBC. The data and information collected will be used to establish the IBC Registry, a private cancer registry.

Approximately 300 persons who are 18 years or older and who have been diagnosed with IBC will participate in this study. Participants will provide researchers with access to their medical and pathology records, slides, tissue, and x-rays. They also will consent to a 15-minute telephone interview concerning general information about themselves and the initial manifestation of IBC and to a 30-minute interview about their medical history.

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Detailed Description

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Inflammatory breast carcinoma (IBC) is an extremely rare, aggressive form of breast carcinoma that disproportionately affects young women. Clinical features of IBC include warmth, redness, edema, skin dimpling and rapid enlargement; the hallmark pathologically is dermal lymphatic invasion. Minimal criteria necessary for a clinical diagnosis of IBC have been debated and relatively little is known about the epidemiology, pathogenesis and molecular characteristics of these very lethal tumors. This project, funded by a grant from the Department of Defense awarded to PHL, would develop a national registry of approximately 300 volunteers (aged 18 years or older) with IBC. Subjects will provide access to medical records, pathology records, slides, blocks and tissue (fixed and frozen) and x-rays and consent to an interview. Recruitment will be performed at collaborating institutions and through an IBC research foundation (Owen Johnson) that maintains a website and e-mail contact lists. The registry resources would be made available collaboratively to anyone in the breast cancer research community, based on merit as determined by a designated committee. Central aims of the study include determining whether clinically or pathologically defined IBC differs in clinical behavior or biologically, identifying markers in IBC that may provide useful information about the aggressive potential of breast cancers generally, and evaluation of tissue for mouse mammary tumor virus (MMTV) related sequences. The purpose of this IRB submission is to review the role of MES as a collaborating pathologist on this study. Enrollment is closed as of this time.

Conditions

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Inflammatory Breast Cancer

Study Design

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Study Time Perspective

RETROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* Patients will be recruited from collaborating institutions throughout the US and through the IBC research foundation (established by patient advocate, Mr. Owen Johnson), which maintains a website and a research e-mail list. The goal is to recruit approximately 300 volunteers, at least 18 years of age or older.

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No