Case-Control Study of Inflammatory Breast Cancer in North Africa
Condition: Diabetes
MeSH terms: Inflammatory Breast Neoplasms
Study type: Observational

Summary: 
      Background:

        -  Inflammatory breast cancer (IBC) is a rare, poorly understood and particularly
           aggressive form of breast cancer.

        -  Three characteristics of IBC tumors their rapid progression, their extensive formation
           of new blood vessels, and the fact that these characteristics are present from the
           inception of the tumor make it an ideal model for studying factors associated with tumor
           aggressiveness.

        -  This study is a collaboration among several institutions in the United States and North
           Africa that have extensive epidemiological experience and experience with IBC.

      Objectives:

      - To understand what causes certain types of breast conditions, including IBC.

      Eligibility:

      - Women 18 years of age and older with IBC and non-IBC and healthy women volunteers are
      eligible. Women who have had a previous diagnosis of any kind of breast cancer are excluded.

      Design:

        -  Participants complete a questionnaire providing information about their background,
           including medical and reproductive history, family health history and lifestyle habits
           and undergo the following additional procedures:

        -  Height, weight, hip and chest measurements.

        -  Saliva sample collection to measure biological factors that may be related to breast
           conditions.

        -  Breast examination and, if permission is given, photographs of affected breast.

        -  Analysis of biopsied tissue for genetic and biochemical factors.
    

Detailed description: 
      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.
    

Observational model: Case-Control
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Patients at study hospitals and visitors to study hospitals.
      
Biospecimen description: 
      saliva, tumor tissue
    
Keywords: Aggressive Breat Cancer