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A Case-Control Study of Inflammatory Breast Cancer in North Africa

18 Years
Open (Enrolling)
Inflammatory Breast Cancer

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Trial Information

A Case-Control Study of Inflammatory Breast Cancer in North Africa

Inflammatory breast cancer (IBC) is a rare, poorly understood and particularly aggressive
form of breast cancer characterized by diffuse erythema and edema/peau d'orange of the
breast. The proposed case-control study of risk factors for IBC will include approximately
400 IBC cases accrued over a two-year period in centers in four countries in North Africa
(the major cancer center and selected private clinicians in Tunisia, the major cancer center
in Egypt, 2 cancer centers in Algeria, and 2 cancer centers in Morocco). Two control groups
will be included: 1) 400 non-IBC breast cancer cases and; 2) 400 visitor controls (excluding
those with breast, ovarian, endometrial, and nasopharyngeal cancers) in the study hospitals.
The study will involve the administration of a questionnaire, anthropometric measurements,
and saliva collection for all study subjects. In addition, digital photographs of the
breasts will be collected for IBC cases, and a clinical examination form and
paraffin-embedded tumor tissue will be collected for IBC cases and non-IOBC breast cancer
controls. The study will be conducted as a consortium, with form development and translation
coordinated at the National Cancer Institute (USA). A review of study procedures will be
done after the first three months of data collection. The National Cancer Institute
(NCI)-Division of Cancer Epidemiology and Genetics (DCEG), NCI-Office of International
Affairs (OIA), University of Michigan, and International Breast Cancer Research Foundation
(IBCRF) will provide funding for the project.

Inclusion Criteria

- The case-control study will be restricted to women at least 18 years of age. IBC
cases will be defined as having any clinical signs of redness, and either edema or
peau d' orange characteristic of IBC or evidence of tumor emboli in the dermal
lymphatics (at the center in Rabat).

Cases with extensive ulceration of the breast or with breast carcinoma 'en cuirasse' will
be excluded from the study, even if erythema is present.

Women with a previous diagnosis of breast cancer will be excluded.

All cancers will be pathologically confirmed with evidence of tumor in either the breast
parenchyma or dermal lymphatics based on the diagnostic biopsy.

Cases newly diagnosed and/or treated at study hospitals will be included.

Type of Study:


Study Design:


Principal Investigator

Catherine Schairer, Ph.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

National Cancer Institute (NCI)


United States: Federal Government

Study ID:




Start Date:

November 2008

Completion Date:

Related Keywords:

  • Inflammatory Breast Cancer
  • Case-Control
  • Inflammatory Breast Cancer
  • North Africa
  • IBC
  • Breast Neoplasms
  • Inflammatory Breast Neoplasms