Surveillance of Complex Renal Cysts - the SOCRATIC Pilot Study (SOCRATICp)

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 outcomes of this strategy for Bosniak III/IV cysts. We first designed a pilot study that will assess the feasibility of a subsequent larger multicenter observational study aiming to ascertain mid-term safety of active surveillance. The objectives of this pilot study are a) Determining patients and urologists buy-in and barriers to the proposed intervention; b) Collecting perceptions and concerns of patients and urologists; c)

Study Overview

• Status: Completed
• Conditions: Renal Cyst

Detailed Description

STUDY DESIGN - This is a two-arm multicenter prospective observational pilot study where patients with Bosniak III or IV choosing either active surveillance or surgery will be monitored closely. OBJECTIVES - PRIMARY Validate the feasibility issues (acceptability, recruitment rate, costs, protocol adherence and implementation of imaging central review) of an observational study on the treatments of complex cysts. SECONDARY a- Validate the inclusion and exclusion criteria in regard to the feasibility of the study; b- Validate the triggers for discontinuation of AS in terms of feasibility and safety for the patients. POPULATION - For the pilot study, the intended targeted population will be patients incidentally diagnosed with a Bosniak III or IV cysts and who opted to be managed by either surgery or active surveillance. METHODOLOGY - Upon written consent, patients will be explained the followup scheme which will consist of a semi-annual visits for 1 year. To mimic the upcoming larger study and to evaluate visit feasibility issues, the baseline and the follow-up visits will consist of the following items: blood results, CT-scan result, quality of life questionnaires and medical data. Baseline (prior to study entry) and follow-up abdominal imaging (CT/MRI) suspicious for progression will be reviewed centrally by an interventional radiologist at the CIUSSSE-CHUS, to confirm Bosniak classification.

• Study Type: Observational
• Enrollment (Actual): 24

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Hamilton, Ontario, Canada
      • St Joseph's Healthcare
    • Toronto, Ontario, Canada
      • Princess Margaret Cancer Center
  • Quebec
    • Sherbrooke, Quebec, Canada, J1H 5N4
      • Centre de recherche du Centre hospitalier Universitaire de Sherbrooke

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

1. aged ≥18 years at the time of diagnosis
2. diagnosed with a Bosniak III or IV cyst
3. size of cystic component ≤7cm
4. solid component ≤2 cm in maximal diameter for Bosniak IV cysts
5. life expectancy >5 years (by physician's estimate)
6. diagnosis ≤6 months from accrual date
7. currently asymptomatic from the disease
8. deemed fit enough for surgery
9. willingness and ability to complete questionnaires in either French or English
10. able and willing to provide informed consent.

Exclusion Criteria:

1. history of a hereditary renal cancer syndrome
2. presence of polycystic kidney disease
3. systemic therapy for another malignancy within 12 months of recruitment date
4. uncontrolled medical illness including infections, hypertension, arrhythmias, heart failure, or myocardial infarction/unstable angina within 6 months that would predispose to immediate surgical therapy
5. metastatic disease or evidence of vascular or nodal disease
6. unwillingness to undergo monitoring and imaging studies
7. any contra-indication(s) to contrast-enhanced imaging (estimated glomerular filtration rate <30min/mL)

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
active surveillance; Patient with Bosniak III or IV lesion that decide to be followed under active surveillance
Surgery; Patient with Bosniak III or IV lesion that decide to undergo a definitive treatment such as surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acceptability	defined by the number of patients that accept to be enrolled over the number of patients that were screened eligible	at baseline (at enrollment, no longer than 6 months after diagnosis)
recruitment rate	defined by the number of patients that actually were enrolled per month per participating site	at baseline (at enrollment, no longer than 6 months after diagnosis)
study costs	defined by costs for research resources involved per patient per participating site	at the end of study (1 year after enrollment/signature of consent)
study compliance	defined by the percentage of total deviations (missing data, missing visits or visits out of timeframe)	at the end of study (1 year after enrollment/signature of consent)

Collaborators and Investigators

• Sponsor: Centre de recherche du Centre hospitalier universitaire de Sherbrooke
• Collaborators: Canadian Urological Association; Kidney Cancer Canada
• Investigators: Principal Investigator: Patrick O Richard, MD,MSc,FRSCS, Centre de recherche du Centre hospitalier Universitaire de Sherbrooke

Study record dates

Study Major Dates

• Study Start (Actual): September 30, 2019
• Primary Completion (Actual): August 31, 2021
• Study Completion (Actual): December 31, 2022

Study Registration Dates

• First Submitted: July 18, 2019
• First Submitted That Met QC Criteria: September 4, 2019
• First Posted (Actual): September 6, 2019

Study Record Updates

• Last Update Posted (Actual): February 15, 2024
• Last Update Submitted That Met QC Criteria: February 13, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: bosniak classification; Bosniak III cyst; Bosniak IV cyst; complex renal mass
• Additional Relevant MeSH Terms: Neoplasms; Kidney Diseases; Urologic Diseases; Pathological Conditions, Anatomical; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Cysts; Kidney Diseases, Cystic
• Other Study ID Numbers: 2020-2871

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Upon completion of the study, the results will be published and disseminated by traditional knowledge transfer activities such as conference presentations (local, national and international meetings) and peer-reviewed manuscript publication.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No