| 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 |
CHU DE QUEBEC – UNIVERSITE LAVAL
11 Côte du Palais
(418) 525-4444
|
| VILLE |
Québec
|
| INVESTIGATEUR(RICE) PRINCIPAL(E) |
Frédéric Pouliot
|
| COORDONATEUR(RICE) |
Marilyn Savard
Marilyn.Savard@crchudequebec.ulaval.ca
418-525-4444 poste 20414
|
| 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)
|
