Actively Recruiting
Exploration of a Holistic Management Procedure for Liver Cancer Surveillance to Improve Early Diagnosis in Chinese Population: Single-Center, Prospective Observational Real-World Study
Led by Ruijin Hospital · Updated on 2023-05-23
20000
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating a liver cancer risk stratification management approach to see if it improves early diagnosis rates of liver cancer in high-risk populations in China. The study focuses on patients with conditions such as chronic hepatitis B and C, cirrhosis, and metabolic dysfunction-associated fatty liver disease. This observational real-world study is conducted by Ruijin Hospital and aims to follow participants for up to three years to monitor liver cancer occurrence and early diagnosis effectiveness. Participants are grouped based on liver cancer risk levels according to local guidelines: very high, high, medium, and low risk. They will undergo liver cancer surveillance at intervals of every 3 months, every 6 months, or annually. Surveillance includes tests such as serum AFP and ultrasound exams to monitor liver health. This management aims to standardize follow-up procedures and improve detection timing. During the study, participants will have regular follow-ups for liver cancer surveillance and risk stratification assessments. Researchers will collect data on early diagnosis rates, the distribution of risk levels at screening and follow-up, and the cumulative incidence of liver cancer over three years. The trial will monitor participants for up to four years collectively, including initial screening and long-term follow-up. Safety and compliance will be tracked throughout the study period.
CONDITIONS
Brief Title
Digitalized Surveillance Management for Liver Cancer Risk Population in Improving Eearly Diagnosis Efficancy in Chinese Population (dSEARCH)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Voluntary participation with signed informed consent and ability to complete trial procedures
- Age between 18 and 75 years old
- Diagnosis of chronic hepatitis B with persistent positive hepatitis B surface antigen for 6 months or more
- Diagnosis of chronic hepatitis C
- Diagnosis of cirrhosis confirmed by liver biopsy, liver stiffness measurement, imaging, or fibrosis scores
- Diagnosis of metabolic dysfunction-associated fatty liver disease with liver fibrosis score F3 or higher
- Diagnosis of metabolic dysfunction-associated fatty liver disease combined with abnormal glucose metabolism
- Family history of liver cancer in first-degree biological relatives
You will not qualify if you...
- Age under 18 years or over 75 years
- Previous diagnosis of liver cancer before enrollment
- Severe mental illness or cognitive impairment
- Pregnancy, lactation, or planning pregnancy
- Participation in other clinical trials within 3 months prior to study
- Judged by doctor as unable to comply with study requirements or unsuitable for participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 4 years
Participants are monitored for liver cancer risk according to their risk level with surveillance visits including serum AFP tests and ultrasound exams.
Visits every 3 months, 6 months, or annually depending on risk group
Trial Site Locations
Total: 1 location
1
Department of Infectious Diseases , Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, China
Actively Recruiting
Research Team
Q
Qing Xie, MD
H
Honglian Gui, MD,PhD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
4
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