Evaluation of Urinary Exosomes Presence From Clear Cell Renal Cell Carcinoma
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: Urinary sample.
- Кому может быть актуально
- Состояния в реестре: Clear Cell Renal Cell Carcinoma. 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
- 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
Clear cell renal cell carcinoma is diagnosed by imaging, sometimes associated with biopsy. This diagnosis is expensive, invasive and sometimes late. The development of a simple biological test for diagnosis is essential. Exosomes are 30 to 150 nm membrane vesicles secreted into the extracellular space by various living cells. These exosomes can be isolated from biological fluids, including urine. The recent study of urinary exosomes is a promising topic for analyzing tumor markers in urine. The investigator's goal is to develop a reliable technique for detecting tumor exosomes in urine in patients with clear cell renal cell carcinoma. The analysis of urinary exosomes could provide a new liquid biopsy tool for the early diagnosis of clear cell renal cell carcinoma.
Подробное описание
The primary objective is to detect urinary exosomes, by electron microscopy technique, from clear cell renal cell carcinoma due to exosome markers (CD9) and clear cell kidney cancer (CA9).
Вмешательства
- Биопрепарат Urinary sample
Urinary sample (100 ml) will be collected in the urology department to analysis urinary exosomes.
Первичные конечные точки
- Number of patients (with clear cell kidney cancer) with CD9+ and CA9+ exosomes by electron microscopy technique [Срок оценки: At inclusion]
Вторичные конечные точки (12)
- Percentage of CD9+ /CA9+ exosomes by electron microscopy technique (%) for patients with clear cell kidney cancer [Срок оценки: At inclusion]
- Percentage of CD9+ /CA9+ exosomes by electron microscopy technique (%) for control patients [Срок оценки: At inclusion]
- Percentage of CD9+ /CA9+ exosomes by flow cytometry (%) for patients with clear cell kidney cancer [Срок оценки: At inclusion]
- Percentage of CD9+ /CA9+ exosomes by flow cytometry (%) for control patients [Срок оценки: At inclusion]
- Percentage of CD9+ /CA9+ exosomes by Reverse Transcription quantitative Polymerase Chain Reaction (RT-qPCR) (%) for control patients [Срок оценки: At inclusion]
- Percentage of CD9+ /CA9+ exosomes by Reverse Transcription quantitative Polymerase Chain Reaction (RT-qPCR) (%) for patients with clear cell kidney cancer [Срок оценки: At inclusion]
- Percentage of CD9+/CD63+/CD81+/CA9+ exosomes by electron microscopy technique (%) for patients with clear cell kidney cancer [Срок оценки: At inclusion]
- Percentage of CD9+/CD63+/CD81+/CA9+ exosomes by electron microscopy technique (%) for control patients [Срок оценки: At inclusion]
- Percentage of CD9+/CD63+/CD81+/CA9+ exosomes by flow cytometry (%) for patients with clear cell kidney cancer [Срок оценки: At inclusion]
- Percentage of CD9+/CD63+/CD81+/CA9+ exosomes by flow cytometry (%) for control patients [Срок оценки: At inclusion]
- Percentage of CD9+/CD63+/CD81+/CA9+ exosomes by Reverse Transcription quantitative Polymerase Chain Reaction (RT-qPCR) (%) for patients with clear cell kidney cancer [Срок оценки: Years: 2]
- Percentage of CD9+/CD63+/CD81+/CA9+ exosomes by Reverse Transcription quantitative Polymerase Chain Reaction (RT-qPCR) (%) for control patients [Срок оценки: Years: 2]
Критерии участия
Критерии включения
Patients:
- All patients with renal mass requiring surgery (partial or total nephrectomy)
- Social security affiliation
- Signed informed consent
Control :
- Unscheduled nephrectomy
- Social security affiliation
- Signed informed consent
Критерии исключения
- Insufficient volume of urine sample (< 100 ml)
- Patients with a urinary catheter
- Patients under court-ordered guardianship or curators
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Модель наблюдения
- Когортное
Центры проведения
Франция · 1 центр
- Chu Saint-Etienne — Saint-Etienne
Публикации
- Li G, Mallouk N, Flandrin P, Garcin A, Lambert C, Berremila SA, Habchi H, Mottet N. Presence of Urinary Exosomes for Liquid Biopsy of Clear Cell Renal Cell Carcinoma: Protocol for a Pilot Feasibility Study. JMIR Res Protoc. 2021 Jul 20;10(7):e24423. doi: 10.2196/24423. PMID 34283029
Идентификаторы
NCT: NCT04053855 · 19CH048 · 2019-A01408-49