tilidad de la Rapamicina para la prevención secundaria de tumores cutáneos en trasplantados renales con recidiva de carcinoma espinocelular - Tumorapa
- Conditions
- El objetivo principal consiste en comparar el efecto de dos estrategias inmunosupresoras, sobre la incidencia de carcinomas espinocelulares nuevos en pacientes receptores de trasplante renal que hayan desarrollado más de un carcinoma espinocelular.To evaluate the impact of two immunosuppressive regimens on the incidence of skin cancers among patients who have had previously a first spinocellulaire skin cancer after transplantation
- Registration Number
- EUCTR2005-004509-27-ES
- Lead Sponsor
- Hospices Civils de Lyon
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 120
Inclusion Criteria
patient aged 18 year old or more with kidney transplant
with immunusuppressive 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 less than 18year 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
Name Time Method Main Objective: Rapamycine replacement of calcineurines inhibitor could reduce the risk of a new skin 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
Name Time Method