Clinical Trial: Pilot Study of Inflammatory Breast Cancer in Egypt and Tunisia

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

Official Title: Pilot Study of Inflammatory Breast Cancer in Egypt and Tunisia

Brief Summary:

One form of breast cancer, known as inflammatory breast cancer (IBC), is characterized by diffuse erythema (redness) and edema (peau d'orange) of the breast. This type of cancer is aggressive and poorly understood. It is rare in the United States (about 4 percent of cases), but more common in Egypt and Tunisia (up to 23 percent of cases). Conducting a case-control study of IBC is complicated by several factors, including the lack of standardized criteria for IBC. In addition, collecting pre-chemotherapy tissue and blood samples from IBC patients is difficult because treatment begins immediately after diagnosis.

In this pilot study, the National Cancer Institute will collaborate with two major cancer centers and two hospitals (in Egypt and Tunisia) to determine the feasibility of a case-control study of IBC. The study will assess the number and characteristics of IBC cases, the feasibility of identifying cases at diagnosis, and the availability of control subjects; will collect frozen pre-treatment tumor tissue from five IBC cases to determine whether RNA isolation is possible; will obtain digital photographs of the breasts of IBC cases; and will demonstrate collaboration between the institutions and personnel involved in the study. The study will last for approximately one year.

Participating hospitals will identify IBC cases. Consenting patients will undergo a breast examination in which the examining surgeon will complete an Initial Examination Form (IEF). Digital photographs of the breasts (but not face) will be taken and linked to the study ID number. Tissue examination results will be entered into the IEF. For five selected cases, additional pre-treatment tumor tissue will be collected and frozen.

This pilot study will assess the availability of controls for a case-con

Detailed Summary:

Breast cancer characterized by diffuse erythema and edema, or peau d'orange, of the breast (inflammatory breast cancer (IBC)) is rare, particularly aggressive, and poorly understood. The extent of redness and edema or peau d'orange, of the breast required for a diagnosis of IBC has not been standardized. According to the most recent American Joint Committee on Cancer (AJCC) definition of inflammatory breast cancer, the signs of redness and edema or peau d'orange, should cover the majority of the breast, and should have arisen quickly. Breast cancers with redness and edema or peau d'orange, account for approximately 4 percent of breast cancers in the United States, but up to 23 percent of breast cancers in Egypt and Tunisia.

The proposed pilot study will determine the feasibility of conducting a case-control study of inflammatory breast cancer in collaboration with the National Cancer Institute-Cairo, Egypt, and the Institut Salah Azaiz, Tunis, Tunisia, the major cancer centers in Egypt and Tunisia, and Cairo University Hospital and Charles Nicolle Hospital, affiliated general hospitals from which controls will be selected. Currently, neither case study hospital collects data on the number of inflammatory breast cancer cases meeting the AJCC definition which will be used for the proposed case-control study. In addition, the geographic distribution of IBC cases at the two study hospitals (knowledge of which is necessary for the selection of appropriate controls) is unknown.

The goals of the pilot study are to assess the feasibility of the following critical components of the case-control study: 1) identifying a sufficient number of IBC cases at the time of diagnosis in the two study hospitals; 2) selecting appropriate hospital-based control subjects; 3) collecting frozen pre-treatment tumor tissue; 4) obtaining digital photo
Sponsor: National Cancer Institute (NCI)

Current Primary Outcome:

Original Primary Outcome:

Current Secondary Outcome:

Original Secondary Outcome:

Information By: National Institutes of Health Clinical Center (CC)

Dates:
Date Received: June 23, 2006
Date Started: September 8, 2004
Date Completion:
Last Updated: January 24, 2017
Last Verified: September 23, 2009