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Набор скоро начнётся NCT06317896

Value of Dynamic Monitoring of Early Recurrence of Hepatocellular Carcinoma After Radical Resection Based on CTCS

— Наблюдательное Hepatocellular Carcinoma Circulating Tumor Cell Recurrence Surgery

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: circulating tumor cells.
Кому может быть актуально
Состояния в реестре: Hepatocellular Carcinoma, Circulating Tumor Cell, Recurrence, Surgery. Базовые параметры: 18 лет — 75 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
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Официальное название

Value of Dynamic Monitoring of Early Recurrence of Hepatocellular Carcinoma After Radical Resection Based on CTCS: a Prospective Cohort Study

Обзор

On the basis of previous retrospective studies, the Task Force will further optimize the CTCs longitudinal surveillance model and initially validate the subclonal origin (CTC-DNA) of recurrent/metastatic foci derived from CTCs at the molecular level in hepatocellular carcinoma, prospective clinical trials will be conducted to further validate the predictive value of the CTCS longitudinal monitoring model in predicting postoperative recurrence of hepatocellular carcinoma, and to verify whether it is earlier than imaging to indicate recurrence, to explore the clinical feasibility of CTCs in guiding postoperative adjuvant therapy of liver cancer, and to provide new ideas for early intervention strategy of liver cancer after operation, to establish a set of standardized clinical scheme of auxiliary treatment for patients with liver cancer after operation for accurate and individualized"Early diagnosis and treatment".

Подробное описание

The recurrence rate of HCC after radical resection is high. MRD is the root cause of HCC recurrence, and the MRD result is an important basis for auxiliary treatment decision-making after radical resection. On the basis of previous retrospective studies, the Task Force will further optimize the CTCs longitudinal surveillance model and initially validate the subclonal origin (CTC-DNA) of recurrent/metastatic foci derived from CTCs at the molecular level in hepatocellular carcinoma, prospective clinical trials will be conducted to further validate the predictive value of the CTCS longitudinal monitoring model in predicting postoperative recurrence of hepatocellular carcinoma, and to verify whether it is earlier than imaging to indicate recurrence, to explore the clinical feasibility of CTCs in guiding postoperative adjuvant therapy of liver cancer, and to provide new ideas for early intervention strategy of liver cancer after operation, to establish a set of standardized clinical scheme of auxiliary treatment for patients with liver cancer after operation for accurate and individualized"Early diagnosis and treatment", to provide high-quality evidence-based medicine for the clinical practice of preventing recurrence after radical hepatectomy

Вмешательства

  • Диагностический тест circulating tumor cells
    blood sample and tissue specimen for circulating tumor cell and DNA will be done to patient with hepatocellular carcinoma

Первичные конечные точки

  • 2-year recurrence-free survival rate [Срок оценки: 2 years]
Вторичные конечные точки (2)
  • Correlation between CTCs status dynamic changes and relapse [Срок оценки: 2 years]
  • Correlation between metastasis，primary tumor and CTCs in blood through NGS and CTC-DNA [Срок оценки: 2 years]

Критерии участия

Критерии включения

  • Male or female patients aged 18-75 years;
  • Preoperative imaging examination diagnosed hepatocellular carcinoma (BCLC) stage 0 /stage A/stage B, eligible for radical surgery;
  • ECOG physical status score is 0-1;
  • Child-Pugh score is 5-6 points (Level A);
  • Not received any anti-tumor therapy;
  • Laboratory tests were at normal levels within 7 days before enrollment.

Критерии исключения

  • Patient can't provide blood samples for CTCs and CTC-DNA testing;
  • Patient with two or more types of tumors at the same time;
  • Non-primary liver lesions;
  • Pregnant or lactating women;
  • Patient with a history of other malignant tumors within the past 5 years or at the same time, except cured skin basal cell carcinoma, cervical carcinoma in situ and thyroid papillary carcinoma;
  • Patient with serious heart disease;
  • Other conditions deemed unsuitable for inclusion by the researcher.

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 · 3 центра
  • The Sixth Affiliated Hospital of South China University of Technology — Foshan
  • Zhujiang Hospital of Southern Medical University — Гуанчжоу
  • Affiliated Cancer Hospital and Institute of Guangzhou Medical University — Гуанчжоу

Идентификаторы

NCT: NCT06317896 · 2024-KY-048-01

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗