Recruiting

Active Surveillance

Sponsor:

Université de Sherbrooke

Code:

NCT04558593

Conditions

Complex Renal Cyst

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Active surveillance

Surgery

Study Details

Brief summary:

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.

Conditions

Complex Renal Cyst

Study ID

NCT04558593

Start date

Feb 2, 2021

Status verified date

May, 2026

Completion date

Sep 20, 2031

Anticipated

Primary completion date

Dec 20, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

330 participants

Anticipated

Interventions and Outcome Measures

Arms

active surveillance

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

surgery

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.

Interventions

Active surveillance

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

Surgery

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

Primary outcome measure

  • 5-year cancer-specific survival [ Time Frame: from the date of enrollment (defined by signed consent) to the end of follow-up (up to 5 years) ]

Central Contacts and Locations

Central contacts

Amelie Tetu

819-346-1110amelie.tetu.ciussse-chus@ssss.gouv.qc.ca

Locations

Prostate Cancer Center

Recruiting

Calgary, Alberta, Canada, T2V 1P9

Principal Investigator:

Bimal Bhindi

Northern Alberta Urology Center

Recruiting

Edmonton, Alberta, Canada, T6G 1Z1

Principal Investigator:

Lucas Dean, MD

Vancouver Prostate Centre

Recruiting

Vancouver, British Columbia, Canada

Principal Investigator:

Miles Mannas, MD

Mens Health Clinic

Recruiting

Winnipeg, Manitoba, Canada

Principal Investigator:

Jay Nayak, MD

Nova Scotia Health Authority

Recruiting

Halifax, Nova Scotia, Canada

Principal Investigator:

Ricardo Rendon, MD

St-Joseph's Hospital

Recruiting

Hamilton, Ontario, Canada

Principal Investigator:

Rahul Bansal, MD

The Ottawa Hospital

Recruiting

Ottawa, Ontario, Canada

Principal Investigator:

Luke Lavallee

Thunder Bay Health Sciences Center

Recruiting

Thunder Bay, Ontario, Canada

Principal Investigator:

Walid Shahrour, MD

Princess Margaret Hospital

Recruiting

Toronto, Ontario, Canada

Principal Investigator:

Antonio Finelli

Woodstock hospital

Recruiting

Woodstock, Ontario, Canada

Principal Investigator:

Philippe Violette, MD

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

Recruiting

Lévis, Quebec, Canada, G6V 3Z1

Principal Investigator:

Matthieu Gratton

CHUM

Recruiting

Montreal, Quebec, Canada

Principal Investigator:

Jean-Baptiste Lattouf

Hôpital Maisonneuve-Rosemont (CISSS-EIMtl)

Recruiting

Montreal, Quebec, Canada

McGill University Health Centre

Recruiting

Montreal, Quebec, Canada

Principal Investigator:

Simon Tanguay

CHU de Québec - Université Laval

Recruiting

Québec, Quebec, Canada

Principal Investigator:

Frédéric Pouliot

Centre de recherche du Centre hospitalier Universitaire de Sherbrooke

Recruiting

Sherbrooke, Quebec, Canada, J1H 5N4

Principal Investigator:

Patrick O Richard

CIUSSS Mauricie-Centre-du-Québec

Recruiting

Trois-Rivières, Quebec, Canada

Principal Investigator:

Felix Couture

More Information

Sponsor

Université de Sherbrooke

Last update posted

Jun 1, 2026

Last verified

May, 2026

Keywords

  • renal cyst
  • complex cyst
  • Bosniak III
  • Bosniak IV
  • renal masses
  • active surveillance
  • monitoring
  • surgery

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Université de Sherbrooke on 2026-06-01.