Drug Induced Liver InjuryNCT06771011
Prospective Comparative Validation Study of RUCAM and RECAM
An observational study of Drug Induced Liver Injury, run by Beijing Friendship Hospital at 1 site in China.
Trial summary
A total of 407 hospitalized patients with acute liver injury in Beijing Friendship Hospital Affiliated to Capital Medical University were enrolled. The clinical information, biochemical examination, imageological examination (ultrasound, CT, MRI) and liver biopsy pathology of patients with acute liver injury will be… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Drug Induced Liver Injury
- How many people
- 407 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2023to 1 May 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Population who met the above inclusion and exclusion criteria
Who may be able to join
- Older than 18 years old
- Acute liver injury within 3 months of onset and biochemical meeting one of the following criteria: ALT≥5 ULN; ALP≥2 ULN; ALT≥3 ULN and TBil≥2 ULN
- The patients had a clear history of medication: the time from medication to onset, the time from drug withdrawal to onset, the time of the first laboratory test and the peak laboratory test, the reason for taking medication, the name of the drug, the dose of the drug, and the frequency. If the causative drug includes traditional Chinese medicine, the specific name of all the components or patent Chinese medicine in the prescription, a single drug or single component, or the main ingredient in the prescription causing liver injury should be provided
- All the key data for RUCAM and RECAM can accurately be contained.
- Follow-up outcomes confirmed that the cause of the acute liver injury was any of the following liver diseases: Drug-induced liver injury, acute viral hepatitis (including acute viral hepatitis A, acute viral hepatitis B or acute exacerbation of chronic hepatitis B, acute viral hepatitis E), alcoholic liver disease, autoimmune hepatitis, biliary calculi, biliary obstruction, hypoxic-ischemic hepatitis, congestive liver disease and other liver diseases
Who cannot join
- The incubation period cannot be accurately calculated: the dates of starting medication, stopping medication, and onset of illness cannot be accurately described, resulting in the inability to calculate the incubation period
- Can not be clear about the pathogenic drug: the pathogenic drug is only described as "traditional Chinese medicine, cold medicine, antipyretic medicine", but cannot be clear about what kind of medicine
- Missing biochemical data, resulting in inability to assess the time of 50% decrease in liver biochemistry (ALT or ALP, TBIL) from the peak after drug withdrawal
- The cause of the patient's acute liver injury could not be determined
- Acetaminophen liver injury
- Toxic liver disease, such as mushroom poisoning caused liver damage, chemical poisons (such as paint, etc.) liver damage
- Previous liver transplantation and bone marrow transplantation
- Pregnancy or lactation
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Beijing Friendship Hospital
Beijing, Beijing Municipality, 100050
Yao Meng, 13011670736, mengyao2954@163.com
About this study
A total of 407 hospitalized patients with acute liver injury in Beijing Friendship Hospital Affiliated to Capital Medical University were enrolled. The clinical information, biochemical examination, imageological examination (ultrasound, CT, MRI) and liver biopsy pathology of patients with acute liver injury will be collected. The diagnostic efficacy of RECAM and RUCAM in the diagnosis of DILI will be compared, and the consistency of different clinicians in the diagnosis of DILI using RECAM and RUCAM scores will also be compared.
Read the detailed description
Patients admitted to Beijing Friendship Hospital affiliated with Capital Medical University from March 2023 to September 2024 who meet the inclusion criteria will be included in the study. Data collected will include demographic information, clinical manifestations, laboratory tests, imaging examinations, and liver pathology reports. Three clinical doctors will independently score the patients, calculating the RECAM and RUCAM scores to compare the diagnostic efficacy of RECAM and RUCAM, as well as the consistency of the two scoring systems in diagnosing DILI. Additionally, statistical analysis will be performed on patients' clinical manifestations, laboratory tests, imaging examinations, and liver pathology reports.
- Conditions
- Drug Induced Liver Injury
- Medical subject headings
- Chemical and Drug Induced Liver Injury
What is being measured
The primary outcome is the main question the study is designed to answer.
RECAM is not inferior to RUCAM
Area under the curve (AUC) values for the identification of DILI cases were compared by the Delong method. The AUROC of RUCAM in diagnosing DILI was higher than RECAM. The pattern of liver injury was classified by the R-value based on the first available liver chemistries. Individual scores of the RUCAM and RECAM were calculated with the appropriate algorithms.
Measured: July 2025
RECAM is inferior to RUCAM
Area under the curve (AUC) values for the identification of DILI cases were compared by the Delong method. The AUROC of RUCAM in diagnosing DILI was higher than RECAM. The pattern of liver injury was classified by the R-value based on the first available liver chemistries. Individual scores of the RUCAM and RECAM were calculated with the appropriate algorithms.
Measured: July 2025
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2025
- Study start1 May 2023
- Primary completion1 Feb 2026 (estimated)
- Study completion1 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Drug Induced Liver InjuryStudies of the same condition, open and under way.
- More trials run by Beijing Friendship HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 407 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Friendship Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Xinyan Zhao, Study chair, Beijing Friendship Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06771011
- Sponsor's protocol ID
- MR-11-23-024371
- Status last verified
- Dec 2024
- First submitted
- 22 Aug 2024
- Last updated
- 13 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Comparative Validation Study of RUCAM and RECAM
- ClinicalTrials.gov ID
- NCT06771011
- Acronym / sponsor ID
- MR-11-23-024371
- Conditions
- Drug Induced Liver Injury
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 407 participants (estimated)
- Lead sponsor
- Beijing Friendship HospitalUniversity, hospital or other
- Study start
- 1 May 2023 (actual)
- Primary completion
- 1 Feb 2026 (estimated)
- Study completion
- 1 May 2026 (estimated)
- First posted
- 13 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A total of 407 hospitalized patients with acute liver injury in Beijing Friendship Hospital Affiliated to Capital Medical University were enrolled. The clinical information, biochemical examination, imageological examination (ultrasound, CT, MRI) and liver biopsy pathology of patients with acute liver injury will be collected. The diagnostic efficacy of RECAM and RUCAM in the diagnosis of DILI will be compared, and the consistency of different clinicians in the diagnosis of DILI using RECAM and RUCAM scores will also be compared.
Detailed description
Patients admitted to Beijing Friendship Hospital affiliated with Capital Medical University from March 2023 to September 2024 who meet the inclusion criteria will be included in the study. Data collected will include demographic information, clinical manifestations, laboratory tests, imaging examinations, and liver pathology reports. Three clinical doctors will independently score the patients, calculating the RECAM and RUCAM scores to compare the diagnostic efficacy of RECAM and RUCAM, as well as the consistency of the two scoring systems in diagnosing DILI. Additionally, statistical analysis will be performed on patients' clinical manifestations, laboratory tests, imaging examinations, and liver pathology reports.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Population who met the above inclusion and exclusion criteria
Key inclusion criteria (5 listed)
- Older than 18 years old
- Acute liver injury within 3 months of onset and biochemical meeting one of the following criteria: ALT≥5 ULN; ALP≥2 ULN; ALT≥3 ULN and TBil≥2 ULN
- The patients had a clear history of medication: the time from medication to onset, the time from drug withdrawal to onset, the time of the first laboratory test and the peak laboratory test, the reason for taking medication, the name of the drug, the dose of the drug, and the frequency. If the causative drug includes traditional Chinese medicine, the specific name of all the components or patent Chinese medicine in the prescription, a single drug or single component, or the main ingredient in the prescription causing liver injury should be provided
- All the key data for RUCAM and RECAM can accurately be contained.
- Follow-up outcomes confirmed that the cause of the acute liver injury was any of the following liver diseases: Drug-induced liver injury, acute viral hepatitis (including acute viral hepatitis A, acute viral hepatitis B or acute exacerbation of chronic hepatitis B, acute viral hepatitis E), alcoholic liver disease, autoimmune hepatitis, biliary calculi, biliary obstruction, hypoxic-ischemic hepatitis, congestive liver disease and other liver diseases
Key exclusion criteria (8 listed)
- The incubation period cannot be accurately calculated: the dates of starting medication, stopping medication, and onset of illness cannot be accurately described, resulting in the inability to calculate the incubation period
- Can not be clear about the pathogenic drug: the pathogenic drug is only described as "traditional Chinese medicine, cold medicine, antipyretic medicine", but cannot be clear about what kind of medicine
- Missing biochemical data, resulting in inability to assess the time of 50% decrease in liver biochemistry (ALT or ALP, TBIL) from the peak after drug withdrawal
- The cause of the patient's acute liver injury could not be determined
- Acetaminophen liver injury
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
RECAM is not inferior to RUCAM
Time frame: July 2025
Area under the curve (AUC) values for the identification of DILI cases were compared by the Delong method. The AUROC of RUCAM in diagnosing DILI was higher than RECAM. The pattern of liver injury was classified by the R-value based on the first available liver chemistries. Individual scores of the RUCAM and RECAM were calculated with the appropriate algorithms.
RECAM is inferior to RUCAM
Time frame: July 2025
Area under the curve (AUC) values for the identification of DILI cases were compared by the Delong method. The AUROC of RUCAM in diagnosing DILI was higher than RECAM. The pattern of liver injury was classified by the R-value based on the first available liver chemistries. Individual scores of the RUCAM and RECAM were calculated with the appropriate algorithms.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Xinyan Zhao study chair
Beijing Friendship Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Drug Induced Liver Injury, run by Beijing Friendship Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xinyan Zhao (13801001732, zhao_xinyan@ccmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
RECAM is not inferior to RUCAM (time frame: July 2025). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2025.