Идёт набор NCT04558593

Surveillance of Complex Renal Cysts - The SOCRATIC Study

— Наблюдательное Complex Renal Cyst

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: Active surveillance, Surgery.
Кому может быть актуально: Состояния в реестре: Complex Renal Cyst. Базовые параметры: от 18 лет · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: Канада, Франция
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Обзор

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.

Подробное описание

Background: One in three patients over 60 years old will be diagnosed with a renal cyst following abdominal imaging. Traditionally, experts have recommended that complex cystic lesions (also known as Bosniak III - IV cysts) should be surgically removed, but recent evidences suggest that many are benign or have low metastatic potential. Thus, active surveillance which involves close follow-up of a patient's condition, was proposed as a tradeoff option to surgery.

Design: Multicenter observational longitudinal prospective cohort study

Objectives: The goal of this multicenter project is to conduct a prospective study with a 5-year follow-up to confirm the oncologic outcomes of active surveillance in the management of complex cysts. The main objectives are: 1) to compare the 5-year cancer specific survival between cysts managed by surgery and active surveillance; 2) to evaluate disease progression; 3) to evaluate patient's well-being according to each management strategy; and 4) to compare the 5-year healthcare cost of both management approaches.

Study population: Patients incidentally diagnosed with a Bosniak III and/or IV cysts, who are deemed to have at least 5 years of life, and who opted to be managed by either surgery or active surveillance. (N=330)

Follow-up: Patients will DECIDE if they want to have a surgery or to be followed by active surveillance. All patients will be followed as per standard of care with either semi-annual and annual visits. Research visits will serve to assess vital status and quality of life scores (through validated questionnaires). Patients on active surveillance will also be assessed for cyst progression and might be offered invasive or systemic therapy if progression is observed.

Вмешательства

Процедура Active surveillance
Per standard of care: Imaging and blood tests every 6 months (3 first years) and annually (following years)
Процедура Surgery
Per standard of care: partial or full resection of the kidney, imaging annually

Первичные конечные точки

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

Вторичные конечные точки (12)

5-year overall survival [Срок оценки: from the date of enrollment (defined by signed consent) to the end of follow-up (up to 5 years)]
2-year overall survival [Срок оценки: from the date of enrollment (defined by signed consent) up to 2 years of follow-up]
2-year cancer-specific survival [Срок оценки: from the date of enrollment (defined by signed consent) up to 2 years of follow-up]
Treatment-free survival [Срок оценки: from the date of enrollment (defined by signed consent) up to 2 and 5 years of follow-up]
Discontinuation rate [Срок оценки: from the date of enrollment (defined by signed consent) to the end of follow-up (up to 5 years)]
Tumor growth rate [Срок оценки: if there is a progression, at the time of imaging (undefined, between 6 months and 5 years post-enrollment)]
Tumor progression rate [Срок оценки: if there is a progression, at the time of imaging (undefined, between 3 months and 5 years post-enrollment)]
Time to tumor progression (Progression-free survival) [Срок оценки: range of time from enrollment to progression (undefined, between 3 months and 5 years post-enrollment) or end of follow-up (5 years post-enrollment)]
Patient and tumor characteristics in correlation with cancer-specific death [Срок оценки: at the baseline visit (no more than 30 days after signed consent)]
Patient and tumor characteristics in correlation with disease progression [Срок оценки: at the baseline visit (no more than 30 days after signed consent)]
Perceived health change over time [Срок оценки: range of time from enrollment to end of follow-up (maximum 5 years post-enrollment)]
Quality of life change over time [Срок оценки: range of time from enrollment to end of follow-up (maximum 5 years post-enrollment)]

Критерии участия

Критерии включения

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

Критерии исключения

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)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет