Clinical trial NCT00793390: Case-Control Study of Inflammatory Breast Cancer in North Africa
Official title: A Case-Control Study of Inflammatory Breast Cancer in North Africa
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes
Keywords: Aggressive Breat Cancer
Lead sponsor: National Institutes of Health Clinical Center (CC)
Sponsor class: NIH
First posted: 2008-11-19
Enrollment: 815
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients at study hospitals and visitors to study hospitals.

Brief 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.

Eligibility 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.

Primary outcomes:
measure: breast cancer
timeFrame: retrospective
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: National Cancer Institute-Cairo
city: Gharbia
country: Egypt
facility: Gharbia Cancer Society
city: Tanta
country: Egypt
facility: Tanta Cancer Center
city: Casablanca
country: Morocco
facility: Ibn Rochd Oncology Center
city: Marrakech
country: Morocco
facility: University Hospital Center Mohammed VI
city: Tunis
country: Tunisia
facility: Institut Salah Azaiz
Study officials:
affiliation: National Cancer Institute (NCI)
name: Gretchen Benson, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: