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临床试验/NCT00793390
NCT00793390已完成不适用

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

National Cancer Institute (NCI)6 个研究点 分布在 3 个国家目标入组 815 人开始时间: 2008年11月17日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
815
试验地点
6
主要终点
breast cancer

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 100 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

breast cancer

时间窗: retrospective

a rare type of breast cancer assessed clinically by study clinicians.

次要结局

未报告次要终点

研究者

申办方类型
Nih
责任方
Sponsor

研究点 (6)

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