| Title |
Surveillance of Complex Renal Cysts - The SOCRATIC Study |
| Protocole ID |
SOCRATIC |
| ClinicalTrials.gov ID |
NCT04558593 |
| Cancer Type(s) |
Kidney |
| Phase |
Other |
| Stage |
|
| Study Type |
Other |
| Drug |
|
| Institution |
CENTRE HOSPITALIER DE L'UNIVERSITE DE MONTREAL
|
| City |
|
| Principal Investigator |
Dr. Fred Saad
|
| Coordinator |
Amal Nadiri
514-890-8000 poste 26074
|
| Status |
Recruiting |
| Activation Date |
22-12-2022 |
| Eligibility Criteria |
- 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
|
| Exclusion Criteria |
- 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)
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Groupe d'étude en oncologie du Québec