Active Surveillance vs Surgery for Complex Renal Cysts

(SOCRATIC Trial)

Recruiting at 18 trial locations

Overseen By Amelie Tetu

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Université de Sherbrooke

Disqualifiers: Hereditary renal cancer, Polycystic kidney, RCC, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

330 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new approach to managing complex kidney cysts, which can sometimes be mistaken for cancer. Instead of immediately opting for surgery, which carries risks, the trial compares active surveillance—such as regular check-ups and scans—to determine if it is a safe alternative. Ideal participants are those recently diagnosed with a specific type of complex kidney cyst (Bosniak III or IV) that currently causes no symptoms.

As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to important medical advancements.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that thermal ablation, a type of surgery, often causes fewer serious side effects than traditional surgery. In some studies, only about 7% of patients who underwent thermal ablation experienced serious issues, such as bleeding, compared to 20% of those who had standard surgery.

In this clinical trial, one group will undergo surgery, which may include thermal ablation or other procedures like partial or total kidney removal. Thermal ablation is generally well-tolerated and might be safer for some patients compared to more invasive surgeries.

The other group in the trial will be under active surveillance. This involves regular check-ups and imaging tests to monitor the kidney cysts, instead of immediate surgery. Active surveillance is a common and safe approach, as it involves careful monitoring without the immediate risks of surgery.

Both options in the trial have their own safety considerations. It is crucial to consult healthcare providers to determine the best approach for each individual situation. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores two different approaches for managing complex renal cysts: active surveillance and surgery. Unlike the typical immediate surgical intervention, active surveillance involves closely monitoring the cysts with regular imaging and tests, potentially avoiding unnecessary surgery. This approach could lead to less invasive management for patients who do not show aggressive disease progression. On the other hand, the surgery arm of the trial allows for personalized treatment decisions, as the type of surgery—whether partial resection, total resection, or thermoablation—is tailored by the physician based on the patient's specific needs. This trial could redefine how doctors decide on the best path forward for patients with complex renal cysts.

What evidence suggests that this trial's treatments could be effective for Bosniak III/IV renal cysts?

Research has shown that many Bosniak III and IV kidney cysts are not cancerous, and those that are cancerous often do not spread quickly. In this trial, participants will undergo either active surveillance or surgery. Active surveillance involves closely monitoring the cysts with regular scans and tests and may be safer than surgery. Surgery for kidney cysts can lead to serious complications, with about 20% of patients experiencing major issues and a small risk of death. In contrast, active surveillance avoids these surgical risks and is becoming a popular alternative. Growing evidence suggests that monitoring these complex cysts might be a wise choice. ^{1 2 3 6 7}

Who Is on the Research Team?

Patrick O Richard, MD,MSc,FRCSC

Principal Investigator

Université de Sherbrooke

Are You a Good Fit for This Trial?

Inclusion Criteria

able and willing to provide informed consent

new diagnosis ≤ 12 months from accrual date;

currently asymptomatic from the disease;

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Baseline visit to assess patient and tumor characteristics

Up to 30 days

1 visit (in-person)

Active Surveillance

Participants in the active surveillance group are closely monitored with imaging and blood tests every 6 months for the first 3 years, then annually

5 years

Semi-annual visits for 3 years, then annual visits

Surgery

Participants in the surgery group undergo surgical intervention as per standard of care

Varies

Follow-up

Participants are monitored for safety and effectiveness after treatment or surveillance

5 years

Annual visits

What Are the Treatments Tested in This Trial?

Interventions

• Active surveillance
• Surgery

How Is the Trial Designed?

Group I: surgery Experimental Treatment 1 Intervention

110 participants will be included in the surgery group. Surgery is done per standard of care. The type of surgery is at the discretion of the treating physician and may include: partial resection, total resection, thermoablation.

Group II: active surveillance Experimental Treatment 1 Intervention

220 participants will be included in the active surveillance group. Active surveillance is close monitoring (every 6 months the first 3 years following diagnosis and annually the following years), done per standard of care Close monitoring include: abdominal imaging (ultrasound, CT or MRI), chest X-ray or CT scan and blood tests

Who Is Running the Clinical Trial?

Université de Sherbrooke

Lead Sponsor

Trials

317

Recruited

79,300+

Canadian Institutes of Health Research (CIHR)

Collaborator

Trials

1,417

Recruited

26,550,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11966547/

Thermal Ablation versus Surgical Resection for ... Recent studies suggest high efficacy and repeatability of thermal ablation, resulting in improved clinical outcomes compared with surgical resection.

2. facs.org facs.org/for-medical-professionals/news-publications/news-and-articles/acs-brief/april-1-2025-issue/thermal-ablation-is-equally-effective-and-safer-than-surgical-resection-for-small-colorectal-liver-metastases/

Thermal Ablation Is Equally Effective and Safer than ... Overall survival was similar (60%) in the two comparison groups. Serious adverse events occurred in 7% of the thermal ablation group and 20% of ...

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1470204524006600

Thermal ablation versus surgical resection of small-size ... Serious adverse events occurred in 11 (7%) of 148 patients in the experimental group and 29 (20%) of 146 in the control group, mostly periprocedural haemorrhage ...

4. cancerimagingjournal.biomedcentral.com cancerimagingjournal.biomedcentral.com/articles/10.1186/s40644-024-00733-4

Survival after thermal ablation versus wedge resection for ... This study compared the survival outcomes after thermal ablation versus wedge resection in patients with stage I non-small cell lung cancer ...

5. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40946121/

Comparative Efficacy of Thermal Ablation and Surgical ... Conclusion: Surgical resection offered superior OS compared to thermal ablation for CRC-LM patients. However, thermal ablation was associated ...

6. thelancet.com thelancet.com/journals/lanonc/article/PIIS1470-2045(24)00660-0/abstract

Thermal ablation versus surgical resection of small-size ... Serious adverse events occurred in 11 (7%) of 148 patients in the experimental group and 29 (20%) of 146 in the control group, mostly ...

7. nature.com nature.com/articles/s41571-025-00994-3

Thermal ablation is safer than resection of colorectal liver ... Results from the phase III COLLISION trial demonstrate that thermal ablation results in noninferior efficacy outcomes and has a superior safety profile ...