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NCT Number: NCT02121730

Identification of 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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU Amiens, Amiens, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire, Amiens

Other

Collaborators

  • CHU ROUEN - HOPITAL DE BOIS-GUILLAUME
  • University Hospital, Caen
  • University Hospital, Lille

Registry information

Official study title

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

Acronym: FRISC

Important dates

Study start
2014
Primary completion
2021
Study completion
2022
First posted
Apr 23, 2014
Registry last updated
Apr 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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