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Case-Control Study of Inflammatory Breast Cancer in North Africa

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ClinicalTrials.gov Identifier: NCT00793390
Recruitment Status : Completed
First Posted : November 19, 2008
Last Update Posted : April 17, 2018
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) )

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.

Condition or disease
Diabetes

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.

Study Type : Observational
Actual Enrollment : 773 participants
Observational Model: Case-Control
Time Perspective: Retrospective
Official Title: A Case-Control Study of Inflammatory Breast Cancer in North Africa
Study Start Date : November 17, 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer




Primary Outcome Measures :
  1. breast cancer [ Time Frame: retrospective ]
    a rare type of breast cancer assessed clinically by study clinicians.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients at study hospitals and visitors to study hospitals.
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00793390


Locations
Egypt
National Cancer Institute-Cairo
Cairo, Egypt
Gharbia Cancer Society
Gharbia, Egypt
Tanta Cancer Center
Tanta, Egypt
Morocco
Ibn Rochd Oncology Center
Casablanca, Morocco
Marrakech University Hospital
Marrakech, Morocco
Tunisia
Institut Salah Azaiz
Tunis, Tunisia
Sponsors and Collaborators
National Cancer Institute (NCI)
Investigators
Principal Investigator: Catherine Schairer, Ph.D. National Cancer Institute (NCI)

Publications:
Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00793390     History of Changes
Other Study ID Numbers: 999909033
09-C-N033
First Posted: November 19, 2008    Key Record Dates
Last Update Posted: April 17, 2018
Last Verified: April 12, 2018

Keywords provided by National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) ):
aggressive breast cancer
Inflammatory Breast Cancer
IBC

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