Informations générales (source: ClinicalTrials.gov)
Surveillance of Complex Renal Cysts - The SOCRATIC Study (SOCRATIC)
Observational
Université de Sherbrooke (Voir sur ClinicalTrials)
février 2021
septembre 2031
24 mai 2025
One third of individuals aged >60 years will be diagnosed with at least one renal cyst
following abdominal imaging. These cystic lesions are categorized according to the
Bosniak classification which categorizes cysts according to their degree of complexity
and risk of malignancy. Growing evidence suggests that a significant proportion of
Bosniak III and IV cysts are benign and that the malignant ones present low metastatic
potential. Since renal surgery carries substantial morbidity (20%) and potential
mortality (0.5%), active surveillance has gained attention as a potential tradeoff to
surgery to overcome overtreatment. Therefore, prospective studies of long-term follow-up
are needed to confirm the oncologic safety of this strategy for patients with Bosniak
III/IV cysts.
This is an multicenter prospective observational longitudinal study. The main objective
is to compare the 5-year follow-up cancer-specific survival between the active
surveillance and the surgical groups.
Etablissements
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CHU Bordeaux (URO-CCR) - Bordeaux - France | Solène Ricard | Contact (sur clinicalTrials) | |||
Critères
Tous
Inclusion Criteria:
- 18 years old and older;
- diagnosed with a Bosniak III or IV cyst (classification 2019);
- size of cystic component ≤7cm;
- cyst wall/septum nodule (obtuse margin of protrusion) <10mm (perpendicular axis) or
nodular/solid component ≤2 cm in any axis;
- life expectancy >5 years (by physician's estimate);
- new diagnosis ≤ 12 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
- 18 years old and older;
- diagnosed with a Bosniak III or IV cyst (classification 2019);
- size of cystic component ≤7cm;
- cyst wall/septum nodule (obtuse margin of protrusion) <10mm (perpendicular axis) or
nodular/solid component ≤2 cm in any axis;
- life expectancy >5 years (by physician's estimate);
- new diagnosis ≤ 12 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
- 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)