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临床试验/NCT02781116
NCT02781116Unknown不适用

Risk Assessment Tool for Breast Cancer in Saudi Arabia

National Guard Health Affairs1 个研究点 分布在 1 个国家目标入组 2,000 人开始时间: 2016年3月最近更新:
适应症

试验速览

阶段
不适用
入组人数
2,000
试验地点
1
主要终点
The number of new breast cancer identified with the new risk assessment model that more applicable for our population

研究概览

简要总结

This study will have great impact and influence in the medical setting as the targeted model that will be derived from this study will be the pioneer in our region. This model will be beneficial in identifying risk factors and its association with the Arab women population. Furthermore, it will bring chemotherapy prevention once the risk factors and the model are established. Risk factors maybe different from those identified in western women by Gail and IBIS Models

详细描述

Breast cancer is the most common cancer worldwide. Incidence and mortality have reached a plateau and appear to be dropping in both United States and parts of Western Europe. This decline has been attributed to several factors such as early detection through the use of screening mammography and appropriate use of systemic adjuvant therapy. Breast cancer is a disease and that is predominantly influenced by risk factors which can be allocated to one of four groups: first, family history / genetic which accounts for 15% of all breast cancer cases. The second group which is the most known risk factor for breast cancer can be linked to hazardous effects of hormonal exposures such as early age at menarche, late age at menopause, small number of children and nulliparity, late age at first birth and little or no breast feeding. Long term use of hormone replacement therapy but apparently not long term use of oral contraceptives is also important. The third group is high mammographic breast density which has been shown to be one of the most significant markers of breast cancer risk and the fourth group is having a history proliferative benign breast disease.

Recently, there is a belief that overall caloric intake and obesity in particular with weight gain are related to increased breast cancer risk with different effects between pre and post menopausal women. Also physical activity appears to be important, above and beyond its effect on weight.

There are scattered studies about breast cancer risk factors in the Arab region. One study was published on March 2002 which investigates risk factors associated with breast cancer in Jordanian women while some studies associate diet with breast cancer. The known / well-established risk factors in the Western countries have not bee systematically validated or proven to play a role in Arab women with breast cancer. Therefore, there is no known risk assessment tool that is applicable to our patient population. No model has not been created yet synthesizing the breast cancer risk factors in Arab women.

Research Impact:

This study will have great impact and influence in the medical setting as the targeted model that will be derived from this study will be the pioneer in our region. This model will be beneficial in identifying risk factors and its association with the Arab women population. Furthermore, it will bring chemotherapy prevention once the risk factors and the model are established. Risk factors maybe different from those identified in western women by Gail and IBIS Models

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • All female patients attended the breast cancer screening center

排除标准

  • Refusal of participation

结局指标

主要结局

The number of new breast cancer identified with the new risk assessment model that more applicable for our population

时间窗: 5 years

次要结局

  • 1. The number of new breast cancer cases using Tyrer Cuzick models that applied in our patients(5 years)
  • Collect number of IVF and ovarian stimulation in prediction of breast cancer(5 years)
  • Collect BMI measure in kg/m^2(5 years)

研究者

申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Nagham Sheblaq, CCRP, BsC. pharma

Research Supervisor

National Guard Health Affairs

研究点 (1)

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