Case-Control Study of Inflammatory Breast Cancer in North Africa

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2013 by National Institutes of Health Clinical Center (CC)
Sponsor:
Information provided by:
National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT00793390
First received: November 18, 2008
Last updated: September 10, 2014
Last verified: November 2013
  Purpose

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.

Condition
Inflammatory Breast Cancer

Study Type: Observational

Resource links provided by NLM:


Further study details as provided by National Institutes of Health Clinical Center (CC):

Estimated Enrollment: 1200
Study Start Date: November 2008
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00793390

Contacts
Contact: Catherine Schairer, Ph.D. (301) 435-3979 schairec@mail.nih.gov

Locations
Algeria
Annaba Cancer Center Recruiting
Annaba, Algeria
Blida Cancer Center Recruiting
Blida, Algeria
Egypt
National Cancer Institute-Cairo Recruiting
Cairo, Egypt
Morocco
Oncology Center Ibn Rochd Recruiting
Casablanca, Morocco
National Institute of Oncology Recruiting
Ri-Rabat, Morocco
Sponsors and Collaborators
Investigators
Principal Investigator: Catherine Schairer, Ph.D. National Cancer Institute (NCI)
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00793390     History of Changes
Other Study ID Numbers: 999909033, 09-C-N033
Study First Received: November 18, 2008
Last Updated: September 10, 2014
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Case-Control
Inflammatory Breast Cancer
North Africa
IBC

Additional relevant MeSH terms:
Breast Neoplasms
Inflammatory Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on September 18, 2014