Liver Cancer Prognosis Investigation Study
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
- Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
- Кому может быть актуально
- Состояния в реестре: Liver Neoplasms. Базовые параметры: 18 лет — 80 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
- Китай
- 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
Liver CAncer PRognosis InvEstigation Study (Liver-CARE)
Обзор
This prospective cohort study is designed to explore the role of environmental, clinical, and genetic risk factors in the progression and prognosis of primary liver cancer (PLC). We will recruit 5000 patients with newly diagnosed, previously untreated PLC. The eligible patients will be asked to complete a baseline survey at the time of initial admission and be followed up every 3 to 6 months after discharge.
Подробное описание
Primary liver cancer (PLC) is highly malignant and is particularly prevalent in China. Multiple factors are involved in the development and progression of PLC. Several large-scale, prospective cohort studies have been established to identify environmental and genetic risk factors for the development of PLC in the general population. However, few cohort studies have focused on determining risk factors beyond clinical prognostic factors for the progression of PLC in patients with PLC. Therefore, we will conduct a prospective cohort study to examine the role of environmental, clinical, and genetic risk factors in the progression and prognosis of PLC. We plan to recruit 5000 patients with newly diagnosed, previously untreated PLC. A baseline survey will be conducted at the time of initial admission, with follow-up at 3 and 6 months after discharge for all patients and thereafter every 3 months for patients treated with interventional therapy and every 6 months for patients receiving surgery and other therapies. We will collect information on patients' demographics characteristics, clinical diagnosis and treatment, lifestyle, nutritional status, psychological and mental status, quality of life, anthropometric data, body composition, routine laboratory tests and examinations, and disease progression through structured questionnaires, physical examinations, and medical record reviews. Deaths will be ascertained through medical records, death certificates, and next-of-kin. Additionally, we will collect blood, urine, stool, and liver tissue samples.
Первичные конечные точки
- Death [Срок оценки: Up to 20 years]
Вторичные конечные точки (9)
- Recurrence (intrahepatic and extrahepatic) [Срок оценки: From date of diagnosis until the date of cancer recurrence or date of death from any cause, whichever came first, assessed up to 20 years]
- Newly Emerging Diseases [Срок оценки: From date of diagnosis until the date of newly emerging diseases or date of death from any cause, whichever came first, assessed up to 20 years]
- Response Evaluation [Срок оценки: through study period, every 3-6 months]
- Nutritional status [Срок оценки: through study period, every 3-6 months]
- Quality of life [Срок оценки: through study period, every 3-6 months]
- Psychological and mental status [Срок оценки: through study period, every 3-6 months]
- Cachexia assessment [Срок оценки: through study period, every 3-6 months]
- Sarcopenia [Срок оценки: through study period, every 3-6 months]
- Frailty [Срок оценки: through study period, every 3-6 months]
Критерии участия
Критерии включения
- Age 18-80 years,
- Diagnosed with primary liver cancer (ICD-10: C22) (Referring to the diagnostic criteria in the "Primary Liver Cancer Diagnosis and Treatment Guidelines (2024 Edition)" and the "2024 CSCO Guidelines for the Diagnosis and Treatment of Biliary Malignancies),
- Have not received any anti-tumor treatment (e.g., surgery, ablation, interventional therapy, radiotherapy, chemotherapy, targeted therapy, immunotherapy, etc),
- Signed informed consent.
Критерии исключения
- Have a history of other malignant tumors,
- Have a history of other serious chronic diseases (e.g., heart failure, liver failure, kidney failure, etc.),
- Expected survival time is no more than 3 months,
- Severe physical or mental disability.
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Модель наблюдения
- Когортное
Центры проведения
Китай · 1 центр
- Sun Yat-sen University Cancer Center — Гуанчжоу
Идентификаторы
NCT: NCT06623734 · SYSU SPH MEC 2024-101