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

NCT ID: NCT02121730

Last Updated: 2018-08-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

2800 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-11-17

Study Completion Date

2019-08-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Cancer of Kidney

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Kidney Transplantation

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

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Universitaire, Amiens

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Gabriel Choukroun, MD, PhD

Role: STUDY_DIRECTOR

CHU Amiens

Marc Hazzan, MD, PhD

Role: STUDY_CHAIR

CHRU LILLE

Bruno Hurault de Ligny, MD, PhD

Role: STUDY_CHAIR

CHU CAEN

Michel Godin, MD, PhD

Role: STUDY_CHAIR

CHU Rouen

Locations

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CHU Amiens

Amiens, , France

Site Status RECRUITING

CHU CAEN

Caen, , France

Site Status NOT_YET_RECRUITING

Chru Lille

Lille, , France

Site Status NOT_YET_RECRUITING

Chu Rouen

Rouen, , France

Site Status NOT_YET_RECRUITING

Countries

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France

Central Contacts

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Gabriel CHOUKROUN, MD, PhD

Role: CONTACT

+333 22 45 58 62

Pauline GUFFROY

Role: CONTACT

Facility Contacts

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Bruno Hurault de Ligny, MD, PhD

Role: primary

Marc HAZZAN, MD, PhD

Role: primary

Michel GODIN, MD, PhD

Role: primary

Other Identifiers

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PI2012_843_0006

Identifier Type: -

Identifier Source: org_study_id

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