Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

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

13. august 2018 opdateret af: Centre Hospitalier Universitaire, Amiens

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.

Studieoversigt

Status

Ukendt

Betingelser

Detaljeret beskrivelse

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.

Undersøgelsestype

Observationel

Tilmelding (Forventet)

2800

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Frankrig
      • Amiens, Frankrig, 80000
        • Rekruttering
        • CHU Amiens
        • Ledende efterforsker:
          • Gabriel Choukroun, MD, PhD
      • Caen, Frankrig, 14000
        • Ikke rekrutterer endnu
        • CHU CAEN
        • Kontakt:
        • Ledende efterforsker:
          • Bruno Bruno Hurault de Ligny, MD, PhD
      • Lille, Frankrig, 59000
        • Ikke rekrutterer endnu
        • Chru Lille
        • Kontakt:
        • Ledende efterforsker:
          • Marc Hazzan, MD, PhD
      • Rouen, Frankrig, 76000
        • Ikke rekrutterer endnu
        • CHU Rouen
        • Kontakt:
        • Ledende efterforsker:
          • Michel Godin, MD, PhD

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

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

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

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

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Association between neoplastic complications and cancers
Tidsramme: 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
10 years

Sekundære resultatmål

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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Centre Hospitalier Universitaire, Amiens

Efterforskere

  • Studieleder: Gabriel Choukroun, MD, PhD, CHU Amiens
  • Studiestol: Marc Hazzan, MD, PhD, Chru Lille
  • Studiestol: Bruno Hurault de Ligny, MD, PhD, CHU CAEN
  • Studiestol: Michel Godin, MD, PhD, CHU Rouen

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

17. november 2014

Primær færdiggørelse (Forventet)

1. august 2019

Studieafslutning (Forventet)

1. august 2019

Datoer for studieregistrering

Først indsendt

22. april 2014

Først indsendt, der opfyldte QC-kriterier

22. april 2014

Først opslået (Skøn)

23. april 2014

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

14. august 2018

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

13. august 2018

Sidst verificeret

1. august 2018

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • PI2012_843_0006

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Kræft i nyre

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Chile

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

3
Abonner