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临床试验/NCT02439554
NCT02439554已完成不适用

Risk Factors for Medium-term Adverse Outcomes and Predictive Modeling for Breast Cancer Patients

Hospital Galdakao-Usansolo1 个研究点 分布在 1 个国家目标入组 1,463 人开始时间: 2013年4月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
1,463
试验地点
1
主要终点
Change in quality of life questionnaire module for breast cancer patients

研究概览

简要总结

This subproject is included in a project coordinated between program groups Evaluation of Health Services of Epidemiology and Public Health (Project CAMISS). The overall objective is to evaluate different aspects of health care received by patients with breast cancer from the diagnostic process, treatment, complications, survival and quality of life, to provide information to improve the effectiveness of interventions, reduce variability, have best predictive rules and increase the quality of life. The main objective of the subproject is to create and validate prospectively predictive rules of recurrence, complications, mortality, changes in quality of life in these patients at admission and one/two years of treatment and to evaluate the external validity of our rules to predict relapses, complications and mortality in the retrospective sample of patients participating in screening programs. Observational methodology with information available from a retrospective cohort of women diagnosed between 2000 and 2009 and another 2-year prospective follow-up included 2040 incident cases of breast cancer in 18 hospitals of 5 regions. Cohorts will learn clinical and health care diagnosis, tumor, treatment, hospital, follow-up (complications, relapse, and vital status) cost and quality of life. Prediction rules are created by means of regression/Cox models at the prospective sample and also investigators will assess the external validity in the retrospective cohort in the case of recurrence, complications and mortality. Expected results: There are currently no results of cohort analysis of the diagnostic process of care that integrates different aspects. The study will create tools to assist prognostic and therapeutic decision making process in these patients

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 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Women over the age of 18 with both incidental in situ and infiltrating breast cancer.

排除标准

  • Lymphoma, sarcoma, lobular carcinoma in situ and inflammatory carcinoma of the breast are excluded

结局指标

主要结局

Change in quality of life questionnaire module for breast cancer patients

时间窗: Change from baseline in quality of life at 2 years

次要结局

  • Mortality data(Mortality at 2 years)

研究者

发起方
Hospital Galdakao-Usansolo
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Susana García Gutiérrez

PhD, Md

Hospital Galdakao-Usansolo

研究点 (1)

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