Case-Control Study of Inflammatory Breast Cancer in North Africa

Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00793390
• Other study ID #: 999909033
• Secondary ID: 09-C-N033
• Status: Completed
• Start date: November 17, 2008
• Est. completion date: September 30, 2018

Study information

• Verified date: December 2020
• Source: National Institutes of Health Clinical Center (CC)
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 815
• Est. completion date: September 30, 2018
• Est. primary completion date: September 30, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 100 Years

Eligibility

• 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.

Related Conditions & MeSH terms

• Diabetes

Locations

Country	Name	City	State
Egypt	National Cancer Institute-Cairo	Cairo
Egypt	Gharbia Cancer Society	Gharbia
Egypt	Tanta Cancer Center	Tanta
Morocco	Ibn Rochd Oncology Center	Casablanca
Morocco	University Hospital Center Mohammed VI	Marrakech
Tunisia	Institut Salah Azaiz	Tunis

Sponsors (1)

Lead Sponsor	Collaborator
National Cancer Institute (NCI)

Countries where clinical trial is conducted

Egypt,  Morocco,  Tunisia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	breast cancer	a rare type of breast cancer assessed clinically by study clinicians.	retrospective