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临床试验/NCT03114826
NCT03114826已完成不适用

Study of the Impact of VEGF Polymorphism on the Development of Renal Carcinoma in Renal Transplant Patients

Centre Hospitalier Universitaire, Amiens1 个研究点 分布在 1 个国家目标入组 272 人开始时间: 2016年10月6日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
272
试验地点
1
主要终点
Taqman allelic discrimination analysis allows to define, for each polymorphism studied, three genotypes: wild homozygote (WT / WT), heterozygote (WT / M), mutated homozygote (M / M). The presence of renal carcinoma was previously confirmed on biopsy.

研究概览

简要总结

Renal transplant patients have on average 3-5 times more risk of developing cancer than the general population. This rate can be increased up to 10 to 15 times in some type of cancer like kidney cancer. Among the identified risk factors, immunosuppressants and, in particular, calcineurin inhibitors (ciclosporin and tacrolimus) play a major role in increasing cancers apart from their depressant effects on the immune system.

Calcineurin inhibitors (CCN) are the basis of immunosuppressive therapy in renal transplantation. Several mechanisms have been implicated to explain their pro-oncogenic properties. One related to an increase in VEGF expression seems particularly interesting in the study of renal cell carcinoma in the transplanted patient. Indeed, the physiopathology of kidney cancer has clearly been associated with an increase in the production of VEGF. Furthermore, some polymorphisms of the gene encoding VEGF have already been associated with the survival of patients with renal carcinoma and the circulating level of VEGF in the general population. The search for an association between the polymorphisms of the VEGF gene and renal carcinoma in renal transplant patients could thus identify patients whose risk of renal cell carcinoma (cRCC) post-transplantation is increased. If the involvement of certain polymorphisms in the development of cRCC was confirmed in this population, their research before the introduction of the immunosuppressive treatment would make it possible to direct the choice of treatment towards molecules without pro-oncogenic property in the Patients such as mTOR protein inhibitors (sirolimus, everolimus). This research project is therefore in line with the desire to move towards a more "personalized" medicine that could be beneficial for the patient.

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

  • •Patients receiving a first, second or third kidney transplant;
  • •Patients receiving a transplant from a living or deceased donor, irrespective of the immunological risk;
  • •Patients with health insurance coverage;
  • •Live or deceased patients for which genomic DNA is available.
  • •in cases : first diagnosis of native kidney cancer (histological type: papillary or clear cell)

排除标准

  • •Minor transplant patients;
  • •Patients transplanted before 1 January 2002;
  • •Patients monitored in the interregion, but transplanted to another center;
  • •Patients receiving a double graft (kidney plus other organ) or a bi-graft;
  • •Patients not accepting that their medical data be included in the register;
  • •Patients not accepting that their specimen be used for scientific research purposes.

研究组 & 干预措施

Renal cell carcinoma in renal transplant patients

干预措施: To study the polymorphism of the gene encoding VEGF (rs699947) as a predictive marker (Genetic)

结局指标

主要结局

Taqman allelic discrimination analysis allows to define, for each polymorphism studied, three genotypes: wild homozygote (WT / WT), heterozygote (WT / M), mutated homozygote (M / M). The presence of renal carcinoma was previously confirmed on biopsy.

时间窗: 1 day

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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