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Efficacité de la rapamycine dans la prévention secondaire des cancers cutanés chez les transplantés rénaux. Etude ouverte randomisée Rapamycine vs anticalcineurines

Conditions
To evaluate the impact of two imnosupressive regimens on the incidence of skin cancers among patients who has a first spinocellular skin cancer after renal transplantation
Registration Number
EUCTR2004-004947-23-BE
Lead Sponsor
F de méthodologie en recherche clinique
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Authorised-recruitment may be ongoing or finished
Sex
All
Target Recruitment
206
Inclusion Criteria

patient aged 18 year old or more with kidney transplant with immunosuppressive treatment with calcineurines inhibitor recurrence of spinocellular carcinoma
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

patient aged les tha 18 year old
metastatic carcinoma
previous treatment with rapamycine
pregnant woman

Study & Design

Study Type
Interventional clinical trial of medicinal product
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Main Objective: Rapapmycine replacement of calcineurines inhibitor could reduce the risk of a new kin cancer by 40% or more while preserving graft function;Secondary Objective: ;Primary end point(s): to analyse the annual incidence of spinocellular carcinoma
Secondary Outcome Measures
NameTimeMethod
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