Recurrent Liver Cancer: Reconceptualization and Reevaluation
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Positive and Negative Predictive Values
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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)
排除标准
- •Pregnant women
- •Those who have received organ transplantation
- •Non-HCC patients diagnosed with other tumors
- •Patients with primary hepatocellular carcinoma complicated by other tumors
- •Those judged by the researcher as not meeting the inclusion criteria
结局指标
主要结局
Positive and Negative Predictive Values
时间窗: Calculated after the threshold value has been determined and applied to the patient data (up to 3 years).
The secondary outcome is to calculate the positive predictive value (PPV) and negative predictive value (NPV) of the novel protein indicator. The PPV represents the probability that patients with an elevated indicator level will experience cancer recurrence, while the NPV represents the probability that patients with a non-elevated indicator level will remain free of recurrence. These values will provide insight into the clinical utility of the indicator.
Sensitivity and Specificity of the Novel Protein Indicator
时间窗: Assessed at the end of the study (up to 3 years), once all patient data has been collected and analyzed.
The primary outcome is to determine the sensitivity and specificity of the novel protein indicator in predicting the recurrence of liver cancer. This will be assessed by constructing a Receiver Operating Characteristic (ROC) curve and establishing a threshold value that maximizes the true positive rate (sensitivity) and minimizes the false positive rate (1-specificity). The ROC curve will visually represent the trade-off between sensitivity and specificity for different threshold values.
次要结局
- Progression-Free Survival (PFS)(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).)
- Overall Survival (OS)(Monitored throughout the study and reported at 1 year, 2 years, and study completion (up to 5 years).)
- Disease-Free Survival (DFS)(Monitored and reported at 6 months, 1 year, 2 years, and study completion (up to 5 years).)
- Time to Progression (TTP)(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).)
研究者
Yewei Zhang
Chief Physician
Nanjing Medical University