| TITRE |
Surveillance de kystes rénaux complexes – Étude SOCRATIC |
| PROTOCOLE ID |
SOCRATIC |
| CLINICAL TRIAL.gov ID |
NCT04558593 |
| TYPE(S) DE CANCER |
Rein |
| PHASE |
Autres |
| TYPE D'ÉTUDE |
Autre |
| INSTITUTION |
CIUSSS DE L'EST-DE-L'ILE-DE-MONTREAL
5415 boul. de l'Assomption
(514) 252-3400
|
| VILLE |
Montréal
|
| INVESTIGATEUR(RICE) PRINCIPAL(E) |
Nawar Hanna
|
| COORDONATEUR(RICE) |
Audrey Lamoureux
audrey.lamoureux.cemtl@ssss.gouv.qc.ca
514-252-3400 poste 6258 Samara Bloom
samara.bloom.cemtl@ssss.gouv.qc.ca
514-252-3400 poste 6244
|
| STATUT |
Actif en recrutement
|
| CRITÈRES D'ÉLIGIBILITÉ |
(EN)
- 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
|
| CRITÈRES D'EXCLUSION |
(EN)
- 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)
|
