Renal CystSOCRATICpNCT04079764
Surveillance of Complex Renal Cysts - the SOCRATIC Pilot Study
An observational study of Renal Cyst, run by Centre de recherche du Centre hospitalier universitaire de Sherbrooke at 3 sites in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Renal Cyst
- Type of treatment
- Injection or infusion
- How many people
- 24 participants
- Where
- 3 sitesCanada
- Study dates
- 30 Sep 2019to 31 Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients incidentally diagnosed with a Bosniak III or IV cysts and who opted to be managed by either surgery or active surveillance
Who may be able to join
- 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
Show all 10Show fewer
- 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.
Who cannot join
- 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)
Trial locations and contacts
3 sites in 1 country.
Canada3 sites
St Joseph's Healthcare
Hamilton, Ontario
Centre de recherche du Centre hospitalier Universitaire de Sherbrooke
Sherbrooke, Quebec, J1H 5N4
Princess Margaret Cancer Center
Toronto, Ontario
About this study
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)
Read the 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.
- Conditions
- Renal Cyst
- Keywords
- bosniak classification, Bosniak III cyst, Bosniak IV cyst, complex renal mass
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Acceptability
defined by the number of patients that accept to be enrolled over the number of patients that were screened eligible
Measured: 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
Measured: 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
Measured: 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)
Measured: at the end of study (1 year after enrollment/signature of consent)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2019
- Study start30 Sep 2019
- Primary completion31 Aug 2021
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal CystStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre de recherche du Centre hospitalier universitaire de Sherbrooke
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Urological Association, Kidney Cancer Canada
- Responsible party
- Sponsor
- Investigators
- Patrick O Richard, MD,MSc,FRSCS, Principal investigator, Centre de recherche du Centre hospitalier universitaire de Sherbrooke
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04079764
- Sponsor's protocol ID
- 2020-2871
- Acronym
- SOCRATICp
- Status last verified
- Feb 2024
- First submitted
- 18 Jul 2019
- Last updated
- 15 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Surveillance of Complex Renal Cysts - the SOCRATIC Pilot Study
- ClinicalTrials.gov ID
- NCT04079764
- Acronym / sponsor ID
- SOCRATICp / 2020-2871
- Conditions
- Renal Cyst
- Keywords
- bosniak classification, Bosniak III cyst, Bosniak IV cyst, complex renal mass
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Centre de recherche du Centre hospitalier universitaire de SherbrookeUniversity, hospital or other
- Collaborators
- Canadian Urological Association, Kidney Cancer Canada
- Study start
- 30 Sep 2019 (actual)
- Primary completion
- 31 Aug 2021 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 6 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients incidentally diagnosed with a Bosniak III or IV cysts and who opted to be managed by either surgery or active surveillance
Key inclusion criteria (10 listed)
- 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)
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Acceptability
Time frame: at baseline (at enrollment, no longer than 6 months after diagnosis)
defined by the number of patients that accept to be enrolled over the number of patients that were screened eligible
recruitment rate
Time frame: at baseline (at enrollment, no longer than 6 months after diagnosis)
defined by the number of patients that actually were enrolled per month per participating site
study costs
Time frame: at the end of study (1 year after enrollment/signature of consent)
defined by costs for research resources involved per patient per participating site
study compliance
Time frame: at the end of study (1 year after enrollment/signature of consent)
defined by the percentage of total deviations (missing data, missing visits or visits out of timeframe)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2024.
- Individual participant dataSharing planned: No. 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.
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Surveillance of Complex Renal Cysts - The SOCRATIC Study
Complex Renal Cyst
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Patrick O Richard, MD,MSc,FRSCS principal investigator
Centre de recherche du Centre hospitalier universitaire de Sherbrooke
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Renal Cyst, run by Centre de recherche du Centre hospitalier universitaire de Sherbrooke at 3 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acceptability (time frame: at baseline (at enrollment, no longer than 6 months after diagnosis)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Feb 2024.