title: Cancer incidence in kidney transplant recipients: a study protocol.
abstract: BACKGROUND
  Different publications show an increased incidence of neoplasms in renal transplant patients. The objective of this study is to determine the incidence of cancer in the recipients of renal transplants performed in the A Coruña Hospital (Spain) during the period 1981-2007.
  
  
  METHODS
  During the study period 1967 kidney transplants were performed, corresponding to 1710 patients. Patients with neoplasms prior to the transplant will be excluded (n = 38). A follow-up study was carried out in order to estimate cancer incidence after transplantation.For each patient, information included donor and recipient characteristics, patients and graft survival and cancer incidence after transplantation. Incident cancer is considered as new cases of cancer after the transplant with anatomopathological confirmation. Their location will be classified according to the ICD-9.The analysis will be calculated using the indirect standardisation method. Age-adjusted cancer incidence rates in the Spanish general population will be obtained from the Carlos III Health Institute, the National Epidemiology Centre of the Ministry of Science and Technology. Crude first, second and third-year post-transplantation cancer incidence rates will be calculated for male and female recipients. The number of cases of cancer at each site will be calculated from data in the clinical records. The expected number of cancers will be calculated from data supplied by the Carlos III Health Institute. For each tumour location we will estimate the standardized incidence ratios (SIRs), using sex-specific cancer incidence rates, by dividing the incidence rate for the transplant patients by the rate of the general population. The 95% confidence intervals of the SIRs and their associated p-values will be calculated by assuming that the observed cancers follow a Poisson distribution. Stratified analysis will be performed to examine the variation in the SIRs with sex and length of follow-up.Competing risk survival analysis methods will be applied to estimate the cumulative incidence of cancer and to identify variables associated to its occurrence.
  
  
  CONCLUSIONS
  Information about cancer incidence in kidney transplant patients could be useful to adapt the guidelines on post-kidney transplant follow-up on tumour screening, and evaluate the impact of intervention measures for the prevention of cancer in these patients.
authors.affiliation: Clinical Epidemiology and Biostatistics Unit, University Hospital Complex of A Coruña, Hotel de Pacientes 7a Planta, As Xubias, A Coruña, Spain. salvador.pita.fernandez@sergas.es
authors.forename: Salvador
authors.initials: S
authors.lastname: Pita-Fernandez
authors.forename: Francisco
authors.initials: F
authors.lastname: Valdes-Cañedo
authors.forename: Sonia
authors.initials: S
authors.lastname: Pertega-Diaz
authors.forename: Maria Teresa
authors.initials: MT
authors.lastname: Seoane-Pillado
authors.forename: Rocio
authors.initials: R
authors.lastname: Seijo-Bestilleiro
mesh_terms: D002985:Clinical Protocols; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D015994:Incidence; D016030:Kidney Transplantation / Q000009:adverse effects*; D008297:Male; D009369:Neoplasms / Q000453:epidemiology* / Q000209:etiology; D012189:Retrospective Studies; D013030:Spain / Q000453:epidemiology
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