| 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'EST-DE-L'ILE-DE-MONTREAL
 PAV. MAISONNEUVE/PAV. MARCEL-LAMOUREUX
5415 boul. de l'Assomption, Montréal, QC, H1T2M4
|
| Ville |
Montréal |
| Investigateur(trice) principal(e) |
Dr Nawar Hanna
|
| Coordonnateur(trice) |
Audrey Lamoureux
514-252-3400 poste 6258
Samara Bloom
514-252-3400 poste 6244
|
| Statut |
 Actif en recrutement |
| Date d'activation |
12-01-2023 |
| 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)
|
Groupe d'étude en oncologie du Québec