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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02121730
Recruitment Status : Recruiting
First Posted : April 23, 2014
Last Update Posted : August 14, 2018
Information provided by (Responsible Party):
Centre Hospitalier Universitaire, Amiens

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.

Condition or disease
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
Estimated Enrollment : 2800 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Identification of Key Risk Factors Associated With Neoplastic Complications After Renal Transplantation in Nord-Pas de Calais, Normandy and Picardy Regions
Actual Study Start Date : November 17, 2014
Estimated Primary Completion Date : August 2019
Estimated Study Completion Date : August 2019

Resource links provided by the National Library of Medicine

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

Primary Outcome Measures :
  1. Association between neoplastic complications and cancers [ Time Frame: 10 years ]
    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

Secondary Outcome Measures :
  1. Risk factors [ Time Frame: 10 years ]
    Identify the main risk factors for developing cancer after transplantation, besides immunosuppressive therapy

  2. Incidence [ Time Frame: 10 years ]
    Evaluate the incidence of neoplastic complications after renal transplantation in interregion Northwest

  3. Typology of cancers [ Time Frame: 10 years ]
    Assess the distribution and respective frequency of different types of cancer, skin and solid tumors in this group of patients

  4. Survival prognosis [ Time Frame: 10 years ]
    Establish the prognosis and survival of transplanted patients with a diagnosis of cancer after transplantation

  5. Survival factors [ Time Frame: 10 years ]
    Analyze the factors associated with the survival of transplanted patients who developed cancer after transplantation

  6. Graft survival [ Time Frame: 10 years ]
    Evaluate graft survival in the group of patients who develop post- transplantation cancer , especially after cancer diagnosis

  7. Rejection number [ Time Frame: 10 years ]
    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

  8. Renal function after cancer [ Time Frame: 10 years ]
    To analyze the evolution of renal function after cancer diagnosis

  9. Cancer management [ Time Frame: 10 years ]
    Analyze the management of these cancers, in particular as regards the strategy of immunosuppressive therapy after cancer diagnosis

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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).

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02121730

Contact: Gabriel CHOUKROUN, MD, PhD +333 22 45 58 62
Contact: Pauline GUFFROY

CHU Amiens Recruiting
Amiens, France, 80000
Principal Investigator: Gabriel Choukroun, MD, PhD         
CHU CAEN Not yet recruiting
Caen, France, 14000
Contact: Bruno Hurault de Ligny, MD, PhD   
Principal Investigator: Bruno Bruno Hurault de Ligny, MD, PhD         
Chru Lille Not yet recruiting
Lille, France, 59000
Contact: Marc HAZZAN, MD, PhD   
Principal Investigator: Marc Hazzan, MD, PhD         
Chu Rouen Not yet recruiting
Rouen, France, 76000
Contact: Michel GODIN, MD, PhD   
Principal Investigator: Michel Godin, MD, PhD         
Sponsors and Collaborators
Centre Hospitalier Universitaire, Amiens
Study Director: Gabriel Choukroun, MD, PhD CHU Amiens
Study Chair: Marc Hazzan, MD, PhD CHRU Lille
Study Chair: Bruno Hurault de Ligny, MD, PhD CHU Caen
Study Chair: Michel Godin, MD, PhD CHU Rouen

Responsible Party: Centre Hospitalier Universitaire, Amiens Identifier: NCT02121730     History of Changes
Other Study ID Numbers: PI2012_843_0006
First Posted: April 23, 2014    Key Record Dates
Last Update Posted: August 14, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Centre Hospitalier Universitaire, Amiens:
grafting kidney

Additional relevant MeSH terms:
Kidney Neoplasms
Carcinoma, Renal Cell
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type