NCT06430983

Recurrent Liver Cancer: Reconceptualization and Reevaluation

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 300 (estimated)
• Sponsor: Nanjing Medical University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• Recurrent Liver Cancer
• Primary Liver Cancer

Timeline

• Start date: 2024-07-01
• Primary completion: 2026-08-01
• Completion: 2027-10-01
• First posted: 2024-05-28
• Last updated: 2024-12-12

Locations

1 site across 1 country: China