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临床试验/NCT04642833
NCT04642833Unknown不适用

Incidence and Clinical-pathological Characteristics of Prostate Cancer in Kidney Transplants Recipients ( KTRs)

University of Florence1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2020年11月18日最近更新:
适应症

试验速览

阶段
不适用
入组人数
30
试验地点
1
主要终点
To investigate the incidence of prostate cancer in patients who underwent to renal transplantation from July 1991 to September 2016

研究概览

简要总结

Kidney transplantation is considered the standard of care for patients with end-stage kidney disease under chronic dialysis treatment. Today, modern surgical techniques have dramatically improved the quality of life and the overall survival of renal transplant recipients (RTRs) . Besides, the use of novel immunosuppressors have increased the 1-year graft survival rate and decreased acute rejection rate . Unfortunately, several transplantation-related diseases including cancer, cardiovascular disease and infection may affect the survival of renal transplant recipients. It has been estimated that RTRs are 2- to 5- fold more likely to develop cancer compared to the general population. Therefore, the development of cancer has become a major concern as it is currently one of the main causes of death in RTRs. The increasing incidence of post-transplant malignancies is generally attributed to immunosuppression which leads to impaired immunosurveillance of cancer cells and virals infections capable of cancer development. Additionally, it has been observed a direct and specific pro-oncogenic effect on RTRs of immunosuppressive drugs and other immunosuppression-independent factors such as the increased age of RTRs, the male gender and the pre-transplant dialysis duration . Prostate cancer is the second most diagnosed cancer in men and the most common non-skin solid neoplasm in RTRs. Generally, the vast majority of post kidney transplantation prostate cancers are localised; however, due to the lack of randomized studies, no specific guidelines for the management of localized prostate cancer are available and, consequently, RTR patients are being treated with surgery or radiotherapy according to national or local guidelines. The concomitant use of immunosuppressors and the presence of the kidney graft in the pelvic cavity make the treatment of localised prostate cancer post kidney transplantation more challenging, highlighting the need for these patients to be addressed to urological oncology centres with surgeons familiar with oncological and transplant surgery.

Prostate cancer is the second most diagnosed cancer in men and the most common non-skin solid neoplasm in RTRs, however, little studies describe the real incidence of prostate cancer in RTRs.

The aim of this study is to retrospectively review a 25-year experience at the Florence Transplant Center in order to evaluate the incidence of prostate cancer and its possible clinical/pathological factors able to influence the survival.

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
40 Years 至 80 Years(Adult, Older Adult)
性别
Male
接受健康志愿者

入选标准

  • Patient undergoing kidney transplantation in the period from July 1991 to September 2016
  • Development of prostate cancer confirmed histologically
  • Written informed consent

排除标准

  • Lack of clinical and prognostic data on selected patients

结局指标

主要结局

To investigate the incidence of prostate cancer in patients who underwent to renal transplantation from July 1991 to September 2016

时间窗: 15 months

次要结局

  • To retrospectively evaluate possible clinical/pathological factors able to influence the survival of prostate cancer in RTRs(15 months)

研究者

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

Donata Villari

Researcher

University of Florence

研究点 (1)

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