Health Trials

Surveillance of Complex Renal Cysts - The SOCRATIC Study

ConditionComplex Renal Cyst
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversité de Sherbrooke

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

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;

Trial population

Patients incidentally diagnosed with a Bosniak III or IV cysts and who opted to be managed by either surgery or active surveillance

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Active surveillance

    Procedure/Surgery

    Per standard of care: Imaging and blood tests every 6 months (3 first years) and annually (following years)

  • Surgery

    Procedure/Surgery

    Per standard of care: partial or full resection of the kidney, imaging annually

Treatment groups

330 Participants
are divided into 2 treatment groups
Group A: active surveillance1 intervention
Group B: surgery1 intervention

Trial outcomes

Primary outcomes

1

5-year cancer-specific survival

Defined as kidney cancer survival 5 years after the enrollment

Time frame
from the date of enrollment (defined by signed consent) to the end of follow-up (up to 5 years)

Secondary outcomes

1

5-year overall survival

Defined as survival 5 years after enrollment

Time frame
from the date of enrollment (defined by signed consent) to the end of follow-up (up to 5 years)
2

2-year overall survival

Defined as survival 2 years after enrollment

Time frame
from the date of enrollment (defined by signed consent) up to 2 years of follow-up
3

2-year cancer-specific survival

Defined as kidney cancer survival 2 years after the enrollment

Time frame
from the date of enrollment (defined by signed consent) up to 2 years of follow-up
4

Treatment-free survival

Defined as survival without treatment (in active surveillance group)

Time frame
from the date of enrollment (defined by signed consent) up to 2 and 5 years of follow-up

Other outcomes

1

Radiomic

Predictive ability of radiomics (comparison between imaging and clinical/research data)

Time frame
On diagnostic imaging, up to 12 months prior consent form

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Université de Sherbrooke

Lead sponsor

Source ClinicalTrials.gov
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