Pilot Study of Inflammatory Breast Cancer in Egypt and Tunisia
2 other identifiers
observational
250
2 countries
4
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-control study by investigating the number and type of admissions to the Ear, Nose, and Throat and Ophthalmology Departments at participating hospitals during 2000-2003, using computerized records.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 8, 2004
CompletedFirst Submitted
Initial submission to the registry
June 23, 2006
CompletedFirst Posted
Study publicly available on registry
June 26, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 27, 2007
CompletedJuly 2, 2017
September 23, 2009
2.6 years
June 23, 2006
June 30, 2017
Conditions
Keywords
Eligibility Criteria
You may qualify if:
- All patients with redness and edema or peau d'orange, of the breast who are seen at the National Cancer-Cairo, Egypt or the Institute Salah Azair in Tunis, Tunisia during the period June 1, 2004 to May 31, 2005 will be eligible for the pilot study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
Cairo University Hospital
Cairo, Egypt
National Cancer Institute-Cairo
Cairo, Egypt
Association Tunisienne de lutte contre le Cancer (ATCC, le conseil
Tunis, Tunisia
Charles Nicolle Hospital, Tunisia
Tunis, Tunisia
Related Publications (3)
Attia-Sobol J, Ferriere JP, Cure H, Kwiatkowski F, Achard JL, Verrelle P, Feillel V, De Latour M, Lafaye C, Deloche C, et al. Treatment results, survival and prognostic factors in 109 inflammatory breast cancers: univariate and multivariate analysis. Eur J Cancer. 1993;29A(8):1081-8. doi: 10.1016/s0959-8049(05)80292-8.
PMID: 8518016BACKGROUNDClasson M, Settleman J. Emerging concepts in tumor progression and therapy. Semin Cancer Biol. 2000 Dec;10(6):393-7. doi: 10.1006/scbi.2000.0338. No abstract available.
PMID: 11170861BACKGROUNDHelal T, Nassiri M, Khalifa A. Immunohistochemical markers of tumor prognosis in breast cancer in Egypt. Cancer Detect Prev. 1997;21(3):201-6.
PMID: 9167036BACKGROUND