Preliminary Experimental Study on Key Technologies for Early Screening of Gastric Cancer
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.
- Кому может быть актуально
- Состояния в реестре: Gastric Cancer, Healthy. Базовые параметры: 18 лет — 100 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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Обзор
This project aims to collect peripheral blood samples from newly diagnosed gastric cancer patients and healthy individuals. Various techniques such as cfDNA sequencing, proteomics, and fragmentomics will be employed to analyze differences in the expression of ctDNA mutations, fragmentomics, and protein biomarkers between gastric cancer patients and healthy individuals. A new comprehensive diagnostic model will be established and its diagnostic value (sensitivity, specificity, accuracy, etc.) for gastric cancer will be validated. Specifically, the study will involve the following subjects and quantities: 700 participants from Zhejiang Cancer Hospital (350 gastric cancer patients and 350 healthy individuals), 200 participants from Sichuan Cancer Hospital (100 gastric cancer patients and 100 healthy individuals), and 200 participants from the Sixth Affiliated Hospital of Sun Yat-sen University (100 gastric cancer patients and 100 healthy individuals). Peripheral blood samples (a total of 15mL from each participant, collected in 3 tubes) will be collected from all subjects. The collected blood samples will undergo multi-omics sequencing including cfDNA methylation sequencing, proteomics, and genomics to establish a multi-omics-based early diagnostic model.
Вмешательства
- Другое No intervention
No intervention measures are needed.
Первичные конечные точки
- Differences in ctDNA gene and tumor-specific proteins expression [Срок оценки: First day in hospital]
Критерии участия
Критерии включения
- Age between 18 and 100 years.
- ECOG performance status of 0 or 1.
- Pathologically confirmed Stage I-III gastric cancer patients.
- Patients who have not undergone any anti-tumor treatment (including chemotherapy, radiotherapy, targeted therapy, surgery, anesthesia, etc.) before blood collection.
- Subjects and their family members who can comprehend the research protocol and are willing to participate in the study, providing written informed consent.
Критерии исключения
- Presence of other hereditary diseases or other tumors.
- Severe inflammatory reactions caused by acute illnesses within 14 days prior to blood draw or use of steroids.
- Previous organ transplantation, stem cell transplantation, bone marrow transplantation, or blood transfusion within the last month before enrollment.
- Pregnant women.
- Participation in other clinical trials requiring medication intake within the last 60 days (including anesthesia).
- Severe cardiovascular diseases, uncontrolled infections, or other uncontrollable comorbidities.
- Subjects or family members unable to comprehend the conditions and objectives of the study.
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Да
Дизайн исследования
- Модель наблюдения
- Когортное
Центры проведения
Китай · 1 центр
- Cancer Hospital of the University of Chinese Academy of Sciences (Zhejiang Cancer Hospital — Ханчжоу
Идентификаторы
NCT: NCT05991947 · IRB-2023-427