Меню
Идёт набор NCT07177742

Prospective Cohort Study on the Relationship Between Exosomal Peroxiredoxin 1 (PRDX1) and Postoperative Liver Metastasis

— Наблюдательное Colorectal Cancer Liver Metastases From Colorectal Cancer Pathology Exosome

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: Observation.
Кому может быть актуально
Состояния в реестре: Colorectal Cancer, Liver Metastases From Colorectal Cancer, Pathology, Exosome. Базовые параметры: 19 мес. — 80 мес. · 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 →

Не всё понятно в терминах? Прочитайте наш гид для пациентов →

Официальное название

Prospective Cohort Study on the Relationship Between Peroxiredoxin 1 (PRDX1) in Blood Exosomes From Colorectal Cancer Radical Resection Specimens and Postoperative Liver Metastasis

Обзор

The occurrence of liver metastasis after curative surgery for resectable colorectal cancer is an important cause of death for patients. Accurately identifying high-risk patients for metastasis and intervening in them has important clinical significance. The pathological examination of surgical specimens failed to fully utilize valuable specimen information and accurately predict liver metastasis; The biomarkers secreted by tumors are metabolized in the liver through the portal vein, especially the particles such as extracellular vesicles secreted by tumors, which are ultimately diluted in peripheral blood and cannot be effectively detected. Our research group extracted an average of 11.25ml of blood (named blood derived from portal vein branch specimens, sdBlood for short) from 8 colorectal cancer radical surgery specimens. Compared with peripheral blood, protein mass spectrometry analysis revealed a significant increase in exosome proteins such as peroxidized redox protein 1 (PRDX1), which are highly correlated with metastasis. This project innovatively uses sdBlood, which has been overlooked by routine pathological examination, to detect the exosomal protein PRDX1 in sdBlood, which is significantly higher than the peripheral blood concentration. A prospective cohort study was established, including 252 patients with pathologically confirmed colorectal cancer after radical surgery. The incidence and time of liver metastasis were followed up and observed. Cox regression statistical analysis was used to determine the correlation between this marker and metastasis and determine its critical value, providing a basis for clinical diagnosis and treatment.

Вмешательства

  • Другое Observation
    Observation.

Первичные конечные точки

  • Liver metastasis. [Срок оценки: From enrollment to 5 years after coloretal radical surgery.]
Вторичные конечные точки (3)
  • Local recurrence. [Срок оценки: From enrollment to 5 years after colorectal radical resection.]
  • Lung metastasis. [Срок оценки: From enrollment to 5 years after colorectal radical resection.]
  • Peritoneal recurrence. [Срок оценки: From enrollment to 5 years after colorectal radical resection.]

Критерии участия

Критерии включения

  • Age between 19-80 years old, gender not limited;
  • Can comply with the requirements of the research visit plan and other protocols;
  • Voluntarily participate and sign an informed consent form; ④ Diagnosed with colon adenocarcinoma through pathological examination; ⑤ Patients who have completed colorectal radical surgery.

Критерии исключения

  • Patients who cannot complete radical surgery for colorectal cancer;
  • Patients with liver diseases (chronic hepatitis B, hepatitis C, severe fatty liver, cirrhosis);
  • Patients who require combined organ resection;
  • Combine patients with other malignant tumors or blood or immune system diseases; ⑤ Prior to tumor resection, any anti-tumor treatment, including radiotherapy, chemotherapy, and molecular targeted therapy, has been performed; ⑥ After surgery, it was found that the mesenteric vein branch of the specimen could not obtain blood due to severe infiltration or other reasons.
  • Patients with severe postoperative complications leading to delayed treatment (Clavien-Dindo grade III or above).

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
  • Shanghai Tongji Hospital, Hepatobilliary Surgery Center, Tongji University — Шанхай

Идентификаторы

NCT: NCT07177742 · K-2024-017

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗