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.
調査の概要
状態
条件
詳細な説明
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.
研究の種類
入学 (予想される)
連絡先と場所
研究場所
-
-
-
Amiens、フランス、80000
- 募集
- CHU Amiens
-
主任研究者：
- Gabriel Choukroun, MD, PhD
-
Caen、フランス、14000
- まだ募集していません
- CHU Caen
-
コンタクト：
- Bruno Hurault de Ligny, MD, PhD
- メール：huraultdeligny-b@chu-caen.fr
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主任研究者：
- Bruno Bruno Hurault de Ligny, MD, PhD
-
Lille、フランス、59000
- まだ募集していません
- CHRU Lille
-
コンタクト：
- Marc HAZZAN, MD, PhD
- メール：m-hazzan@chru-lille.fr
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主任研究者：
- Marc Hazzan, MD, PhD
-
Rouen、フランス、76000
- まだ募集していません
- CHU Rouen
-
コンタクト：
- Michel GODIN, MD, PhD
- メール：michel.godin@chu-rouen.fr
-
主任研究者：
- Michel Godin, MD, PhD
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
サンプリング方法
調査対象母集団
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
コホートと介入
グループ/コホート |
|---|
|
Kidney Transplantation
Patients who had undergone renal transplantation for 10 years in the interregion Northwest (Normandy, Picardy and Nord-Pas de Calais).
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Association between neoplastic complications and cancers
時間枠：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
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Risk factors
時間枠：10 years
|
Identify the main risk factors for developing cancer after transplantation, besides immunosuppressive therapy
|
10 years
|
|
Incidence
時間枠：10 years
|
Evaluate the incidence of neoplastic complications after renal transplantation in interregion Northwest
|
10 years
|
|
Typology of cancers
時間枠：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
時間枠：10 years
|
Establish the prognosis and survival of transplanted patients with a diagnosis of cancer after transplantation
|
10 years
|
|
Survival factors
時間枠：10 years
|
Analyze the factors associated with the survival of transplanted patients who developed cancer after transplantation
|
10 years
|
|
Graft survival
時間枠：10 years
|
Evaluate graft survival in the group of patients who develop post- transplantation cancer , especially after cancer diagnosis
|
10 years
|
|
Rejection number
時間枠：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
時間枠：10 years
|
To analyze the evolution of renal function after cancer diagnosis
|
10 years
|
|
Cancer management
時間枠：10 years
|
Analyze the management of these cancers, in particular as regards the strategy of immunosuppressive therapy after cancer diagnosis
|
10 years
|
協力者と研究者
捜査官
- スタディディレクター：Gabriel Choukroun, MD, PhD、CHU Amiens
- スタディチェア：Marc Hazzan, MD, PhD、CHRU Lille
- スタディチェア：Bruno Hurault de Ligny, MD, PhD、CHU Caen
- スタディチェア：Michel Godin, MD, PhD、CHU Rouen
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (予想される)
研究の完了 (予想される)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
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