Surveillance of Complex Renal Cysts - the SOCRATIC Pilot Study

NCT04079764 | Completed

• 1 other identifier: 2020-2871
• Study Type: observational
• Target: 24
• Locations: 1 country
• Sites: 3

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 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)

Conditions

Renal Cyst

Keywords

bosniak classification; Bosniak III cyst; Bosniak IV cyst; complex renal mass

Outcome Measures

Primary Outcomes (4)

• 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)

Study Arms (2)

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• aged ≥18 years at the time of diagnosis
• diagnosed with a Bosniak III or IV cyst
• size of cystic component ≤7cm
• solid component ≤2 cm in maximal diameter for Bosniak IV cysts
• life expectancy \>5 years (by physician's estimate)
• diagnosis ≤6 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.

You may not qualify if:

• history of a hereditary renal cancer syndrome
• presence of polycystic kidney disease
• systemic therapy for another malignancy within 12 months of recruitment date
• 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)

Sponsors & Collaborators

• Centre de recherche du Centre hospitalier universitaire de Sherbrooke: lead
• Canadian Urological Association: collaborator
• Kidney Cancer Canada: collaborator

Study Sites (3)

St Joseph's Healthcare

Hamilton, Ontario, Canada

Location

Princess Margaret Cancer Center

Toronto, Ontario, Canada

Location

Centre de recherche du Centre hospitalier Universitaire de Sherbrooke

Sherbrooke, Quebec, J1H 5N4, Canada

Location

Study Officials

• Patrick O Richard, MD,MSc,FRSCS

  Centre de recherche du Centre hospitalier universitaire de Sherbrooke

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 18, 2019
• First Posted: September 6, 2019
• Study Start: September 30, 2019
• Primary Completion: August 31, 2021
• Study Completion: December 31, 2022
• Last Updated: February 15, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

CA (3)