Идёт набор NCT06430983

Recurrent Liver Cancer: Reconceptualization and Reevaluation

— Наблюдательное Recurrent Liver Cancer Primary Liver 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: Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
Кому может быть актуально: Состояния в реестре: Recurrent Liver Cancer, Primary Liver Cancer. 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: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Обзор

The goal of this observational study is to determine if a specific protein can serve as a novel indicator for the recurrence of liver cancer. The study will focus on recurrent liver cancer patients and compare participants to primary liver cancer patients as controls. The primary purpose is to assess whether the elevated levels of this protein can be used to monitor the recurrence of liver cancer. The main questions it aims to answer are: Is the levels of the protein significantly elevated in recurrent liver cancer patients compared to primary liver cancer patients? Can the protein be used as a reliable biomarker for the early detection of liver cancer recurrence? Researchers will compare the protein levels in the following groups: 50 recurrent liver cancer patients (training set) with abnormally high levels of the protein. 250 recurrent liver cancer patients (validation set) to confirm the protein's elevation in a separate cohort. Participants will be required to: * Provide blood samples for protein analysis. * Undergo regular follow-up visits for monitoring and data collection. * Allow access to their medical records for relevant clinical information.

Подробное описание

As part of the patient registry, investigators will implement the following registration procedures and other quality factors:

Screening and Recruitment: Eligible patients will be screened and recruited through hospital liver cancer outpatient clinics and wards. Patients must meet the diagnostic criteria for recurrent or primary liver cancer and be willing to participate in the study.

Data Collection: Clinical information of participants will be collected, including demographic characteristics, medical history, treatment regimens, and follow-up outcomes. Data will be entered and verified by professionals to ensure accuracy and completeness.

Quality Control: Strict quality control measures will be implemented, including data audits, sample management, and laboratory testing. Regular reviews and validations of the data will be conducted to ensure the reliability and replicability of the study results.

Data Security: The privacy and personal information of participants will be protected. All data will be stored in a secure environment and comply with relevant laws, regulations, and ethical guidelines.

Ethical Review: The research protocol has been approved by the ethics committee, ensuring that the conduct of the study meets ethical standards and the protection of patient rights.

Первичные конечные точки

Sensitivity and Specificity of the Novel Protein Indicator [Срок оценки: Assessed at the end of the study (up to 3 years), once all patient data has been collected and analyzed.]
Positive and Negative Predictive Values [Срок оценки: Calculated after the threshold value has been determined and applied to the patient data (up to 3 years).]

Вторичные конечные точки (4)

Overall Survival (OS) [Срок оценки: Monitored throughout the study and reported at 1 year, 2 years, and study completion (up to 5 years).]
Progression-Free Survival (PFS) [Срок оценки: Assessed at each follow-up visit, every 3 months for the first 2 years, then every 6 months until study completion (up to 5 years).]
Disease-Free Survival (DFS) [Срок оценки: Monitored and reported at 6 months, 1 year, 2 years, and study completion (up to 5 years).]
Time to Progression (TTP) [Срок оценки: Measured from the initiation of the study intervention until progression or defined worsening, assessed at each follow-up visit (every 3 months for the first 2 years, then every 6 months until study completion, up to 5 years).]

Критерии участия

Критерии включения

Diagnosed with primary hepatocellular carcinoma or diagnosed with non-HCC
The patient or the patient's legal representative must be able to read, understand, and sign the informed consent form
Agree to provide blood samples and have good clinical compliance
Complete clinical basic information, including: the patient's unique traceability number (ID card number/outpatient number/health insurance card number), age, gender, imaging and/or pathological diagnosis results (for patients with primary liver disease), imaging examination confirmed heteromorphic liver cancer (for non-HCC patients)