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Surveillance of Complex Renal Cysts - the SOCRATIC Study

Complex Renal Cyst

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.

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Participation Requirements

  • Sex:

    ALL

  • Eligible Ages:

    18 and up

Participation Criteria

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

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)

Study Location

Vancouver Prostate Centre
Vancouver Prostate Centre
Vancouver, British Columbia
Canada

Contact Study Team

Primary Contact

Kate O'Connor

Backup Contact

Miles Mannas, MD

The Ottawa Hospital
The Ottawa Hospital
Ottawa, Ontario
Canada

Contact Study Team

Backup Contact

Luke Lavallee

Primary Contact

David Yachnin

Centre intégré de santé et de services sociaux de Chaudière-Appalaches - Hôtel-Dieu de Lévis
Centre intégré de santé et de services sociaux de Chaudière-Appalaches - Hôtel-Dieu de Lévis
Lévis, Quebec
Canada

Contact Study Team

Backup Contact

Matthieu Gratton

Primary Contact

Estel Duquet-Deblois

CHU de Québec - Université Laval
CHU de Québec - Université Laval
Québec, Quebec
Canada

Contact Study Team

Backup Contact

Frédéric Pouliot

Primary Contact

Marilyn Savard

Northern Alberta Urology Center
Northern Alberta Urology Center
Edmonton, Alberta
Canada

Contact Study Team

Backup Contact

Lucas Dean, MD

Primary Contact

Stacey Broomfield

St-Joseph's Hospital
St-Joseph's Hospital
Hamilton, Ontario
Canada

Contact Study Team

Primary Contact

Marie Therese Balart

Backup Contact

Rahul Bansal, MD

Woodstock hospital
Woodstock hospital
Woodstock, Ontario
Canada

Contact Study Team

Primary Contact

Rachel Gutschon

Backup Contact

Philippe Violette, MD

McGill University Health Centre
McGill University Health Centre
Montreal, Quebec
Canada

Contact Study Team

Primary Contact

Rodrigo Skowronski

Backup Contact

Simon Tanguay

Mens Health Clinic
Mens Health Clinic
Winnipeg, Manitoba
Canada

Contact Study Team

Backup Contact

Jay Nayak, MD

Primary Contact

Harliv Dhillon

Thunder Bay Health Sciences Center
Thunder Bay Health Sciences Center
Thunder Bay, Ontario
Canada

Contact Study Team

Primary Contact

Shalyn Littlefield

Backup Contact

Walid Shahrour, MD

CHUM
CHUM
Montreal, Quebec
Canada

Contact Study Team

Primary Contact

Amal Nadiri

Backup Contact

Jean-Baptiste Lattouf

Centre de recherche du Centre hospitalier Universitaire de Sherbrooke
Centre de recherche du Centre hospitalier Universitaire de Sherbrooke
Sherbrooke, Quebec
Canada

Contact Study Team

Primary Contact

Shawn Byrns-Corbeil

Backup Contact

Patrick O Richard

Prostate Cancer Center
Prostate Cancer Center
Calgary, Alberta
Canada

Contact Study Team

Backup Contact

Bimal Bhindi

Primary Contact

Lora Mendoza

Nova Scotia Health Authority
Nova Scotia Health Authority
Halifax, Nova Scotia
Canada

Contact Study Team

Backup Contact

Dani Clegg

Primary Contact

Kelly MacDonald

Backup Contact

Ricardo Rendon, MD

Princess Margaret Hospital
Princess Margaret Hospital
Toronto, Ontario
Canada

Contact Study Team

Primary Contact

Thisun Saram

Backup Contact

Antonio Finelli

Hôpital Maisonneuve-Rosemont (CISSS-EIMtl)
Hôpital Maisonneuve-Rosemont (CISSS-EIMtl)
Montreal, Quebec
Canada

Contact Study Team

Primary Contact

Samara Bloom

Backup Contact

Nawar Hanna, MD

Study Sponsored By
Université de Sherbrooke
Participants Required
More Information
Study ID: NCT04558593