Recurrent Liver Cancer: Reconceptualization and Reevaluation

Primary Liver Cancer Clinical Trial

Official title:

Recurrent Liver Cancer: Reconceptualization and Reevaluation

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06430983
• Other study ID #: 2024KY16401
• Status: Not yet recruiting
• Start date: July 1, 2024
• Est. completion date: October 1, 2027

Study information

• Verified date: May 2024
• Source: Nanjing Medical University
• Contact: zhang yewei, doctor
• Phone: +86 13813885788
• Email: zhangyewei[@]njmu.edu.cn
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 300
• Est. completion date: October 1, 2027
• Est. primary completion date: August 1, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• 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)

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Liver Neoplasms
• Primary Liver Cancer
• Recurrence

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Nanjing Medical University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sensitivity and Specificity of the Novel Protein Indicator	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.	Assessed at the end of the study (up to 3 years), once all patient data has been collected and analyzed.
Primary	Positive and Negative Predictive Values	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.	Calculated after the threshold value has been determined and applied to the patient data (up to 3 years).
Secondary	Overall Survival (OS)	Overall survival (OS) is a critical endpoint that measures the length of time from the start of the study until the death of a patient. It provides an assessment of the long-term outcome for patients with liver cancer and will be used to evaluate the prognostic value of the novel protein indicator.	Monitored throughout the study and reported at 1 year, 2 years, and study completion (up to 5 years).
Secondary	Progression-Free Survival (PFS)	Progression-free survival (PFS) is the length of time during and after the treatment of a disease that a patient lives without the disease getting worse. In the context of this study, PFS will be used to measure the time from study entry until the cancer progresses or the patient dies from any cause, providing an intermediate endpoint that reflects the control of disease progression.	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).
Secondary	Disease-Free Survival (DFS)	Disease-free survival (DFS) is the period after treatment during which there is no evidence of active cancer. It is a measure of the effectiveness of treatment in eliminating cancer cells. DFS will be calculated from the time of treatment initiation until the first sign of cancer recurrence or the end of the study.	Monitored and reported at 6 months, 1 year, 2 years, and study completion (up to 5 years).
Secondary	Time to Progression (TTP)	Time to progression (TTP) is the interval from the start of treatment until the tumor progresses or the patient's condition worsens to a defined level. This endpoint is particularly relevant for evaluating the effectiveness of the novel protein indicator in predicting and monitoring disease progression.	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).