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Kidney Diseases, Cystic

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Female Urogenital Diseases and Pregnancy Complications

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Renal Cell Carcinoma

Clear Cell Renal Cell Carcinoma

Patients undergo excision of a renal mass by partial or radical nephrectomy and will be followed by UISS risk classification.

Patients enter active surveillance protocol. Delayed surgery on active surveillance will be recommended if progression from Bosniak 3 to 4 or a solid mass is noted on imaging by radiologist

Delayed surgery is performed if cystic mass radiologically upgrades into Bosniak 4 or solid mass in the active surveillance.

Delayed surgery

Partial or radical nephrectomy is performed as treatment of Bosniak 3 cystic mass

Immediate surgery

Harry Nisén, Adj. professor

Juhana Rautiola

Harry Nisén

The incidence of renal cysts is rising due to increased abdominal imaging. Renal complicated cysts have been traditionally classified according to the Bosniak classification, which distinguishes cystic masses by specific features of walls and septa. The categories I and II are benign and class IIF most probably benign but needs a short radiological follow-up. Categories III and IV have been traditionally operated due to the increased risk of renal cell carcinoma. However, recently published studies show that approximately 50% of the operated Bosniak III cystic masses are benign, which means that half of the cases are overtreated by surgery. It has also been shown that surgical pathology of stable Bosniak IIF cysts is malignant in less than 1%, while the cysts, which are upgraded to higher Bosniak classes will show malignant surgical pathology in 85%. So far, there is lack of prospective data on active surveillance in Bosniak III cystic masses.

The aim of the study is to compare active surveillance and surgery in patients with Bosniak III renal cystic masses. Patients will be randomized in active surveillance or immediate surgical excision of a cystic mass. In the active surveillance group, patients are followed according to the study protocol for 10 years and treated with delayed surgery if the cystic mass upgrades into Bosniak IV/solid, becomes symptomatic or grows over a preclassified threshold. The primary objective is to compare surgical pathology between patients treated with immediate surgery versus delayed surgery.

According to recent retrospective data, active surveillance of Bosniak III cystic masses is reasonable and oncologically safe. Therefore a prospective randomized controlled trial is needed to get high level evidence to support a change in the treatment strategy. The study may significantly reduce unnecessary operations performed in patients with Bosniak III cystic masses.

Comparison of Surgery and Active Surveillance in the Treatment of Bosniak III Renal Cysts

A Prospective Multicenter Trial Comparing Surgery Versus Active Surveillance In Patients With Bosniak 3 Renal Cystic Masses, A NoRenCa And FinnKidney Study

All IPD that underlie results in a publication.

Helsinki University Central Hospital

Adjunct professor

Pathological Conditions, Anatomical

Patient with Bosniak III or IV lesion that decide to be followed under active surveillance

Patient with Bosniak III or IV lesion that decide to undergo a definitive treatment such as surgery

Patrick O Richard, MD,MSc,FRSCS

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 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.

Surveillance of Complex Renal Cysts - the SOCRATIC Pilot Study

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.

defined by the number of patients that accept to be enrolled over the number of patients that were screened eligible

defined by the number of patients that actually were enrolled per month per participating site

defined by costs for research resources involved per patient per participating site

defined by the percentage of total deviations (missing data, missing visits or visits out of timeframe)

Canadian Urological Association

Kidney Cancer Canada

Centre de recherche du Centre hospitalier universitaire de Sherbrooke

The high-throughput extraction of large amounts of quantitative image features from radiographic medical images

Radiomics

More than 200,000 new cases of renal cancer are diagnosed in the world each year, with more than 63,000 new cases in Europe alone. Of those, renal cell carcinoma (RCC) is the most common type in adults, making up more than 90% of the cases. Deciding on the benign or malignant nature of some RCC on the basis of medical images (CT, MRI, US) is an issue, which often leads to unnecessary surgery, morbidity and costs.

A categorization for renal cysts was introduced in the late 1980s known as the Bosniak classification. The Bosniak classification system classifies them into groups that are benign (I and II) and those that need surgical resection (III and IV), based on specific imaging features. However, defining the malignancy of category III lesions still remains a challenge. Though Bosniak classification for renal cysts is used worldwide and underwent a number of modifications, Bosniak III cysts still have almost a 1:1 chance of being malignant. So the problem is that approximately half of the Bosniak category III cystic lesions prove to be benign after surgery.

The proposed project aims to develop a quantitative image analysis (QIA) based multifactorial decision support system (mDSS) capable of classifying renal cysts with high accuracy into benign or malignant status, thus reducing the amount of unnecessary surgeries performed. Using standard-of-care CT images and clinical parameters, the customized DSS will then guide experts in planning a safe and effective diagnostic and treatment strategy for all RCC patients.

The Potential of Radiomics to Differentiate Between Malignant and Benign Bosniak 3 Renal Cysts.

Machine learning algorithm that can differentiate between malignant and beingn bosniak 3 renal cysts.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Comparison of Surgery and Active Surveillance in the Treatment of Bosniak III Renal Cysts	NCT04670887	Cystic Renal Di... Kidney Cancer Surgery	Delayed surgery Immediate surge...	50 Years - 75 Years	Helsinki University Central Hospital
Surveillance of Complex Renal Cysts - the SOCRATIC Pilot Study	NCT04079764	Renal Cyst		18 Years -	Centre de recherche du Centre hospitalier universitaire de Sherbrooke
The Potential of Radiomics to Differentiate Between Malignant and Benign Bosniak 3 Renal Cysts.	NCT03552497	Renal Cyst Comp...	Radiomics	-	Maastricht University

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