Case-Control Study of Inflammatory Breast Cancer in North Africa

NCT ID: NCT00793390

Last Updated: 2020-12-24

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 815 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2008-11-17
• Study Completion Date: 2018-09-30

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.

Conditions

Diabetes

Keywords

Aggressive Breat Cancer

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: RETROSPECTIVE

Study Groups

inflammatory breast cancer cases

inflammatory breast cancer cases

No interventions assigned to this group

non-inflammotory breast cancer cases

non-inflammatory breast cancer cases

No interventions assigned to this group

visitor controls without cancer

visitor controls without breast cancer- those visiting cancer patients

No interventions assigned to this group

Eligibility Criteria

Exclusion Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Gretchen Benson, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

National Cancer Institute (NCI)

Locations

National Cancer Institute-Cairo

Cairo, , Egypt

Gharbia Cancer Society

Gharbia, , Egypt

Tanta Cancer Center

Tanta, , Egypt

Ibn Rochd Oncology Center

Casablanca, , Morocco

University Hospital Center Mohammed VI

Marrakesh, , Morocco

Institut Salah Azaiz

Tunis, , Tunisia

Countries

Algeria; Egypt; Morocco; Tunisia

Other Identifiers

09-C-N033

Identifier Type: -

Identifier Source: secondary_id

999909033

Identifier Type: -

Identifier Source: org_study_id