Actively Recruiting
Prospective Comparative Validation Study of RUCAM and RECAM for Diagnosing Drug-Induced Liver Injury
Led by Beijing Friendship Hospital · Updated on 2025-01-13
407
Participants Needed
1
Research Sites
12 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying hospitalized patients with acute liver injury to compare two scoring systems, RECAM and RUCAM, for diagnosing drug-induced liver injury (DILI). This observational study collects clinical, biochemical, imaging, and pathology data to evaluate the accuracy and consistency of these diagnostic tools. The study aims to understand whether RECAM performs as well as RUCAM in identifying DILI cases. Participants admitted between March 2023 and September 2024 will have their demographic information, clinical symptoms, lab results, imaging scans (ultrasound, CT, MRI), and liver biopsy pathology reports collected. Three clinicians independently score each patient using RECAM and RUCAM to compare their diagnostic effectiveness and agreement. Statistical analyses will also explore relationships among clinical features, lab tests, imaging, and pathology. During the study, patients' medical and diagnostic data will be thoroughly reviewed and scored by clinicians. The main outcome is to determine if RECAM is not inferior or inferior to RUCAM by July 2025. No treatments are given as this is an observational study. Participants will be monitored through their hospital stay and follow-up evaluations to confirm diagnoses and collect outcome information until the study ends in May 2026.
CONDITIONS
Brief Title
Prospective Comparative Validation Study of RUCAM and RECAM
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults older than 18 years and up to 85 years
- Acute liver injury within 3 months of onset with specific biochemical criteria (ALT ≥ 5 times ULN; ALP ≥ 2 times ULN; or ALT ≥ 3 times ULN and total bilirubin ≥ 2 times ULN)
- Clear history of medication use including details of timing, drug name, dose, frequency, and reason for use
- Availability of all key data needed to calculate RUCAM and RECAM scores
- Follow-up confirming the cause of acute liver injury as drug-induced liver injury or other specified liver diseases
You will not qualify if you...
- Incubation period cannot be accurately calculated due to unclear medication or illness dates
- Unclear identification of the causative drug
- Missing biochemical data preventing assessment of liver biochemistry decrease after drug withdrawal
- Undetermined cause of acute liver injury
- Acetaminophen-related liver injury
- Toxic liver diseases such as mushroom poisoning or chemical poison damage
- Previous liver or bone marrow transplantation
- Pregnancy or lactation
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 3 months from acute liver injury onset
Participants undergo diagnostic assessments including clinical evaluations, laboratory tests, imaging examinations, and liver pathology reports to calculate RECAM and RUCAM scores.
1 to 2 visits depending on assessments needed
Duration - Up to 3 years until study completion
Participants are followed up to confirm the cause of acute liver injury and observe clinical outcomes.
Periodic follow-up visits as scheduled
Trial Site Locations
Total: 1 location
1
Beijing Friendship Hospital
Beijing, Beijing Municipality, China, 100050
Actively Recruiting
Research Team
X
Xinyan Zhao
Y
Yao Meng
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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