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

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

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.

Study Overview

• Status: Completed
• Conditions: Cancer of Kidney

Detailed 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.

• Study Type: Observational
• Enrollment (Actual): 2500

Contacts and Locations

Study Locations

• France
  • Amiens, France, 80000
    • CHU AMIENS
  • Caen, France, 14000
    • CHU CAEN
  • Lille, France, 59000
    • CHRU Lille
  • Rouen, France, 76000
    • CHU Rouen

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients who had undergone renal transplantation for 10 years in the French interregion Northwest (Normandy, Picardy and Nord-Pas de Calais).

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Kidney Transplantation; Patients who had undergone renal transplantation for 10 years in the interregion Northwest (Normandy, Picardy and Nord-Pas de Calais).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Risk factors	Identify the main risk factors for developing cancer after transplantation, besides immunosuppressive therapy	10 years
Incidence	Evaluate the incidence of neoplastic complications after renal transplantation in interregion Northwest	10 years
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
Survival prognosis	Establish the prognosis and survival of transplanted patients with a diagnosis of cancer after transplantation	10 years
Survival factors	Analyze the factors associated with the survival of transplanted patients who developed cancer after transplantation	10 years
Graft survival	Evaluate graft survival in the group of patients who develop post- transplantation cancer , especially after cancer diagnosis	10 years
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
Renal function after cancer	To analyze the evolution of renal function after cancer diagnosis	10 years
Cancer management	Analyze the management of these cancers, in particular as regards the strategy of immunosuppressive therapy after cancer diagnosis	10 years

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire, Amiens
• Collaborators: University Hospital, Caen; University Hospital, Lille; CHU ROUEN - HOPITAL DE BOIS-GUILLAUME
• Investigators: Study Director: Gabriel Choukroun, MD, PhD, CHU AMIENS; Study Chair: Marc Hazzan, MD, PhD, CHRU Lille; Study Chair: Michel Godin, MD, PhD, CHU Rouen; Study Chair: Bruno Hurault de Ligny, MD, PhD, University Hospital, Caen

Publications and helpful links

General Publications

• Pommerolle P, Assem M, Uhl M, De Sousa P, Guerrot D, Hazzan M, Lobbedez T, Fourdinier O, Choukroun G. Renal Cell Carcinoma in Native Kidney After Kidney Transplantation: A Multicenter Case Control Study With a Focus on Screening Strategy. Transpl Int. 2025 Jun 16;38:14487. doi: 10.3389/ti.2025.14487. eCollection 2025.

Study record dates

Study Major Dates

• Study Start (Actual): November 17, 2014
• Primary Completion (Actual): November 13, 2021
• Study Completion (Actual): August 15, 2022

Study Registration Dates

• First Submitted: April 22, 2014
• First Submitted That Met QC Criteria: April 22, 2014
• First Posted (Estimated): April 23, 2014

Study Record Updates

• Last Update Posted (Actual): April 28, 2026
• Last Update Submitted That Met QC Criteria: April 23, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Cancer; grafting kidney
• Additional Relevant MeSH Terms: Urogenital Diseases; Urogenital Neoplasms; Neoplasms by Site; Male Urogenital Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urologic Neoplasms; Neoplasms; Kidney Neoplasms
• Other Study ID Numbers: PI2012_843_0006

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No