Identification of Key Risk Factors Associated With Neoplastic Complications After Renal Transplantation in Nord-Pas de Calais, Normandy and Picardy Regions
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 2,500
- 试验地点
- 4
- 主要终点
- Association between neoplastic complications and cancers
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Kidney Transplantation
Patients who had undergone renal transplantation for 10 years in the interregion Northwest (Normandy, Picardy and Nord-Pas de Calais).
结局指标
主要结局
Association between neoplastic complications and cancers
时间窗: 10 years
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
次要结局
- Risk factors(10 years)
- Typology of cancers(10 years)
- Incidence(10 years)
- Cancer management(10 years)
- Renal function after cancer(10 years)
- Survival prognosis(10 years)
- Survival factors(10 years)
- Graft survival(10 years)
- Rejection number(10 years)