Identification of Risk Factors Associated With Neoplastic Complications After Renal Transplantation in Nord-Pas de Calais , Normandy and Picardy Regions

Cancer of Kidney Clinical Trial

— FRISC  

Official title:

Identification of Key Risk Factors Associated With Neoplastic Complications After Renal Transplantation in Nord-Pas de Calais, Normandy and Picardy Regions

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02121730
• Other study ID #: PI2012_843_0006
• Status: Recruiting
• Start date: November 17, 2014
• Est. completion date: August 2019

Study information

• Verified date: August 2018
• Source: Centre Hospitalier Universitaire, Amiens
• Contact: Gabriel CHOUKROUN, MD, PhD
• Phone: +333 22 45 58 62
• Email: choukroun.gabriel[@]chu-amiens.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2800
• Est. completion date: August 2019
• Est. primary completion date: August 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cancer of Kidney
• Carcinoma, Renal Cell
• Kidney Neoplasms

Locations

Country	Name	City	State
France	CHU Amiens	Amiens
France	CHU CAEN	Caen
France	Chru Lille	Lille
France	Chu Rouen	Rouen

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire, Amiens

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Association between neoplastic complications and cancers	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	10 years
Secondary	Risk factors	Identify the main risk factors for developing cancer after transplantation, besides immunosuppressive therapy	10 years
Secondary	Incidence	Evaluate the incidence of neoplastic complications after renal transplantation in interregion Northwest	10 years
Secondary	Typology of cancers	Assess the distribution and respective frequency of different types of cancer, skin and solid tumors in this group of patients	10 years
Secondary	Survival prognosis	Establish the prognosis and survival of transplanted patients with a diagnosis of cancer after transplantation	10 years
Secondary	Survival factors	Analyze the factors associated with the survival of transplanted patients who developed cancer after transplantation	10 years
Secondary	Graft survival	Evaluate graft survival in the group of patients who develop post- transplantation cancer , especially after cancer diagnosis	10 years
Secondary	Rejection number	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	10 years
Secondary	Renal function after cancer	To analyze the evolution of renal function after cancer diagnosis	10 years
Secondary	Cancer management	Analyze the management of these cancers, in particular as regards the strategy of immunosuppressive therapy after cancer diagnosis	10 years