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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04642833
Other study ID # DVillari
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date November 18, 2020
Est. completion date August 2021

Study information

Verified date December 2020
Source University of Florence
Contact Donata Villari, MD
Phone 3387079707
Email donata.villari@unifi.it
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Recruiting
Enrollment 30
Est. completion date August 2021
Est. primary completion date January 18, 2021
Accepts healthy volunteers No
Gender Male
Age group 40 Years to 80 Years
Eligibility Inclusion Criteria: - Patient undergoing kidney transplantation in the period from July 1991 to September 2016 - Development of prostate cancer confirmed histologically - Written informed consent Exclusion Criteria: • Lack of clinical and prognostic data on selected patients

Study Design


Locations

Country Name City State
Italy University of Florence Florence

Sponsors (7)

Lead Sponsor Collaborator
University of Florence Gabriella Nesi, Giandomenico Roviello, Graziano Vignolini, Pietro Spatafora, Sergio Serni, Simone Caroassai

Country where clinical trial is conducted

Italy, 

Outcome

Type Measure Description Time frame Safety issue
Primary To investigate the incidence of prostate cancer in patients who underwent to renal transplantation from July 1991 to September 2016 15 months
Secondary To retrospectively evaluate possible clinical/pathological factors able to influence the survival of prostate cancer in RTRs 15 months
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