Actively Recruiting

Age: 18Years - 75Years
All Genders
ID05870969

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

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Surveillance

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

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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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