Urine Omics Predicting IO Therapy Responses in mRCC Patients
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: No intervention required.
- Кому может быть актуально
- Состояния в реестре: Metastatic Renal Cell Carcinoma. Базовые параметры: от 20 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
- Тайвань
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
Urine Metabolomics and Proteomics Profiling to Predict the Responses and Adverse Events of Immuno-Oncology-based Therapy in Patients With Advanced Renal Cell Carcinoma
Обзор
The study aims to identify urinary metabolite and protein markers that can predict anti-tumor efficacy and adverse events in subjects receiving IO-based therapies for metastatic renal cell carcinoma.
Подробное описание
This is a multi-center single-arm translational study where patients with mRCC who are to receive pre-determined IO-based therapy will be invited to participate the study. After signing the approved informed consent, eligible and consenting subjects will donate their fresh urine samples for subsequent untargeted metabolomics and proteomics study via GS-MS/MS and/or LC-MS/MS to identify potential metabolite and protein markers that are able to predict efficacy and side effects of IO-based therapies. All subjects in the first-line, maintenance after 1st line, second-line, or subsequent lines of IO-based therapy will be invited and recruited, but those who have received any IO-based therapy before the study can NOT be recruited.
Вмешательства
- Другое No intervention required
No intervention required
Первичные конечные точки
- Objective Response Rate (ORR) [Срок оценки: 7 years]
- Progression-free survival (PFS) [Срок оценки: 7 years]
- Duration of response (DOR) [Срок оценки: 7 years]
- Overall survival (OS) [Срок оценки: 7 years]
- Adverse event of special interest (AESI) [Срок оценки: 7 years]
Критерии участия
Критерии включения
- Age > 20 years
- Subjects diagnosed as advanced or metastatic renal cell carcinoma (a/mRCC)
- Subjects who are about to receive IO-based therapy
- ECOG performance 0, 1, 2, and 3
- Life expectancy >3 months
- eGFR > 15 ml/min/1.73 m2 (Stage IV Chronic Kidney Disease or better)
- Willing to sign the informed consent form
Критерии исключения
- Subjects NOT willing to sign the informed consent form
- Subjects with active infection or active urinary tract infection, as shown by urinary WBC > 5/HPF
- Subjects having co-existing other malignancies that need active treatment. Those subjects with other malignancies that do not need active treatment are allowed to join the study.
- Subjects taking any immune-modulating agents, including but not limited to corticosteroid, immune-suppressants, etc. at the discretion of recruiting investigators
- Subjects who have taken any IO-based therapy before.
- Subjects who have received other systemic anti-cancer therapies within 4 weeks of screening are not allowed. However, subjects who had a washout period of the above agents for >4 weeks are allowed to enroll. Subjects who have received or are receiving targeted therapy are allowed to join the study.
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Модель наблюдения
- Когортное
Центры проведения
Тайвань · 1 центр
- National Taiwan University Hospital — Taipei
Идентификаторы
NCT: NCT04712305 · 202011088RIN