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

NCT02121730 | Completed

• 1 other identifier: PI2012_843_0006
• Study Type: observational
• Target: 2,500
• Locations: 1 country
• Sites: 4

Brief 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.

Conditions

Cancer of Kidney

Keywords

grafting kidney; Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• Risk factors

  10 years

• Incidence

  10 years

• Typology of cancers

  10 years

• Survival prognosis

  10 years

• Survival factors

  10 years

Study Arms (1)

Kidney Transplantation

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Caen: collaborator
• University Hospital, Lille: collaborator
• CHU ROUEN - HOPITAL DE BOIS-GUILLAUME: collaborator
• Centre Hospitalier Universitaire, Amiens: lead

Study Sites (4)

CHU Amiens

Amiens, 80000, France

Location

CHU CAEN

Caen, 14000, France

Location

Chru Lille

Lille, 59000, France

Location

Chu Rouen

Rouen, 76000, France

Location

Related Publications (1)

• 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.

  PMID: 40590038 RESULT

MeSH Terms

Conditions

Kidney Neoplasms; Neoplasms

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases

Study Officials

• Gabriel Choukroun, MD, PhD

  CHU Amiens

  STUDY DIRECTOR

• Marc Hazzan, MD, PhD

  CHRU LILLE

  STUDY CHAIR

• Bruno Hurault de Ligny, MD, PhD

  University Hospital, Caen

  STUDY CHAIR

• Michel Godin, MD, PhD

  CHU Rouen

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 22, 2014
• First Posted: April 23, 2014
• Study Start: November 17, 2014
• Primary Completion: November 13, 2021
• Study Completion: August 15, 2022
• Last Updated: April 28, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (4)