Titre Surveillance of Complex Renal Cysts - The SOCRATIC Study
Protocole ID SOCRATIC
ClinicalTrials.gov ID NCT04558593
Type(s) de cancer Rein
Phase Autres
Type étude Autre
Institution CIUSSS DE L'ESTRIE – CENTRE HOSP. UNIV. DE SHERBROOKE
   HOPITAL FLEURIMONT
      3001 12e Avenue Nord, Sherbrooke, QC, J1H 5N4
Ville Sherbrooke
Investigateur(trice) principal(e) Dr Patrick Richard
Coordonnateur(trice) Elsie Morneau
 819-346-1110 poste 12827
Statut Actif en recrutement
Critètes d'éligibilité
  • 18 years old and older;
  • diagnosed with a Bosniak III or IV cyst;
  • size of cystic component ≤7cm;
  • cyst wall/septum nodule <1cm for Bosniak III cysts;
  • solid component ≤2 cm in maximal diameter for Bosniak IV cysts;
  • life expectancy >5 years (by physician's estimate);
  • diagnosis ≤ 6 months from accrual date;
  • currently asymptomatic from the disease;
  • deemed fit enough for surgery;
  • willingness and ability to complete questionnaires in either French or English;
  • able and willing to provide informed consent
Critètes d'exclusion
  • history of a hereditary renal cancer syndrome;
  • presence of polycystic kidney disease;
  • any prior history of RCC;
  • received systemic therapy for another malignancy within the 12 months prior to accrual;
  • uncontrolled medical illness including infections, hypertension, arrhythmias, heart failure, or myocardial infarction/unstable angina within 6 months that would predispose to immediate surgical therapy;
  • metastatic disease or evidence of vascular or nodal disease;
  • unwillingness to undergo monitoring and imaging studies;
  • any contra-indication(s) to contrast-enhanced imaging (estimated glomerular filtration rate <30min/mL)
  • refusing to be co-enrolled in CKCis registry (when applicable in CKCis participating centers)