Identification of Risk Factors Associated With Neoplastic Complications After Renal Transplantation in Nord-Pas de Calais , Normandy and Picardy Regions (FRISC)
Identification of Key Risk Factors Associated With Neoplastic Complications After Renal Transplantation in Nord-Pas de Calais, Normandy and Picardy Regions
Kidney transplantation is now the treatment of choice for end-stage renal disease (ESRD). Between 2800 and 3000 kidney transplants are performed each year in France and more than 33 000 patients are living with a functioning graft.
Preventing allograft rejection requires the use of immunosuppressive therapy, the intensity decreases as the distance from the day of transplantation. Unfortunately, treatment favors certain complications, including infectious and neoplastic. These represent a major cause of mortality in these patients. If the frequency of skin cancer is greatly increased in this population, that of solid tumors remains a concern. Approximately 20% of patients develop cancer after 10 years of graft , half non- skin cancers, the main risk factor is immunosuppressive therapy .
The aim of the study is to evaluate, in a large population of patients treated in 4 regions ( the Nord-Pas de Calais, the Upper and Lower Normandy and Picardy) risk factors (in particular the nature of the immunosuppressive treatment) of developing a neoplastic complication, skin cancers and solid tumors, after renal transplantation.
研究概览
地位
条件
详细说明
A retrospective analysis of the previous 10 years, from 2002 to 2011 will be conducted. This study will better understand the epidemiology of these complications but also allow to identify risk factors associated, including demographic, environmental and related to immunosuppressive therapy.
Thereafter, we hope to implement preventive measures or prospective studies, allowing us to reduce the prevalence of this complication.
研究类型
注册 (预期的)
联系人和位置
学习地点
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Amiens、法国、80000
- 招聘中
- Chu Amiens
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首席研究员：
- Gabriel Choukroun, MD, PhD
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Caen、法国、14000
- 尚未招聘
- CHU CAEN
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接触：
- Bruno Hurault de Ligny, MD, PhD
- 邮箱：huraultdeligny-b@chu-caen.fr
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首席研究员：
- Bruno Bruno Hurault de Ligny, MD, PhD
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Lille、法国、59000
- 尚未招聘
- Chru Lille
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接触：
- Marc HAZZAN, MD, PhD
- 邮箱：m-hazzan@chru-lille.fr
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首席研究员：
- Marc Hazzan, MD, PhD
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Rouen、法国、76000
- 尚未招聘
- CHU Rouen
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接触：
- Michel GODIN, MD, PhD
- 邮箱：michel.godin@chu-rouen.fr
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首席研究员：
- Michel Godin, MD, PhD
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
描述
Inclusion Criteria:
- All adult renal transplant patients in the 4 centers of interregion North - West
- Patients transplanted during the period from 1 January 2002 and 31 December 2011
- Patients recipients of first, second or third renal transplantation
- Patients transplant recipients from a living or deceased donor whatever the immunological risk
- Eligible patients will be included after being informed by their doctor and after accepting their data to be processed in the framework of this study
- Patient with a health insurance coverage
Exclusion Criteria:
- Patients transplanted as child
- Patients transplanted before 1 January 2002
- Patients followed in the interregion but transplanted in another center
- Patients recipients of a double transplant (two kidneys or kidney plus other organ)
- Patients that do not accept their medical data to be included in the database
学习计划
研究是如何设计的？
设计细节
队列和干预
团体/队列 |
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Kidney Transplantation
Patients who had undergone renal transplantation for 10 years in the interregion Northwest (Normandy, Picardy and Nord-Pas de Calais).
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Association between neoplastic complications and cancers
大体时间：10 years
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Correlation, in a population of renal transplant patients followed in interregion Northwest, of the association of neoplastic complications after renal transplantation, skin cancers and solid tumors outside the non-Hodgkin's lymphoma and the terms of immunosuppressive treatment used
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10 years
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Risk factors
大体时间：10 years
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Identify the main risk factors for developing cancer after transplantation, besides immunosuppressive therapy
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10 years
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Incidence
大体时间：10 years
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Evaluate the incidence of neoplastic complications after renal transplantation in interregion Northwest
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10 years
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Typology of cancers
大体时间：10 years
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Assess the distribution and respective frequency of different types of cancer, skin and solid tumors in this group of patients
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10 years
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Survival prognosis
大体时间：10 years
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Establish the prognosis and survival of transplanted patients with a diagnosis of cancer after transplantation
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10 years
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Survival factors
大体时间：10 years
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Analyze the factors associated with the survival of transplanted patients who developed cancer after transplantation
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10 years
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Graft survival
大体时间：10 years
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Evaluate graft survival in the group of patients who develop post- transplantation cancer , especially after cancer diagnosis
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10 years
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Rejection number
大体时间：10 years
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Determine the number of cellular acute rejection and humoral rejections in patients who developed cancer and those free from this complication and analyze the prevalence of releases in the period following the diagnosis of cancer
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10 years
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Renal function after cancer
大体时间：10 years
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To analyze the evolution of renal function after cancer diagnosis
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10 years
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Cancer management
大体时间：10 years
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Analyze the management of these cancers, in particular as regards the strategy of immunosuppressive therapy after cancer diagnosis
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10 years
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合作者和调查者
调查人员
- 研究主任：Gabriel Choukroun, MD, PhD、Chu Amiens
- 学习椅：Marc Hazzan, MD, PhD、Chru Lille
- 学习椅：Bruno Hurault de Ligny, MD, PhD、CHU CAEN
- 学习椅：Michel Godin, MD, PhD、CHU Rouen
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (预期的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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肾癌的临床试验
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Swansea University完全的
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Scripps Translational Science Institute完全的