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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT04595734
Registration number
NCT04595734
Ethics application status
Date submitted
14/10/2020
Date registered
20/10/2020
Titles & IDs
Public title
Liver Toxicity in Lung Cancer Patients Treated With Immune-checkpoint Inhibitors.
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Scientific title
A Retrospective Study of Clinical Outcomes and Liver-related Toxicity of Patients With Lung Cancer Treated With Immune-checkpoint Inhibitors
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Secondary ID [1]
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2019/PID14816
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Lung Cancer Stage IV
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0
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Lung Cancer, Non-small Cell
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Hepatitis
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Condition category
Condition code
Cancer
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0
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Lung - Mesothelioma
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Cancer
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0
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Lung - Non small cell
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Cancer
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0
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Lung - Small cell
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Intervention/exposure
Study type
Observational
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Patient registry
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
Other interventions - No intervention due to observational methods of study
Other interventions: No intervention due to observational methods of study
No intervention due to observational methods of study
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Intervention code [1]
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Other interventions
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Number of participants with immune-mediated hepatitis
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Assessment method [1]
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Timepoint [1]
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Week 6-12 from treatment commencement
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Primary outcome [2]
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Baseline risk factors significantly correlated with hepatic immune-related adverse events
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Assessment method [2]
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Blood test results, BMI, FibroScan data will be correlated with the development of liver toxicity
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Timepoint [2]
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Week 0
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Secondary outcome [1]
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Number of participants with non-hepatic immune-related adverse events
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Assessment method [1]
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Timepoint [1]
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Week 3-32 from treatment commencement
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Secondary outcome [2]
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Baseline risk factors significantly correlated with non-hepatic immune-related adverse events
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Assessment method [2]
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Blood test results and BMI will be correlated with the development of immune-related adverse events (non-hepatic)
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Timepoint [2]
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Week 0
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Eligibility
Key inclusion criteria
1. - Advanced lung cancer (stage IV)
2. - Treatment - immune-checkpoint inhibitors or chemotherapy
3. - Data is fully available for the whole period of observation
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Minimum age
No limit
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
1. - Radiologically reported liver metastases
2. - Concurrent treatment with both therapeutic regimes
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Study design
Purpose
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Duration
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Selection
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Timing
Retrospective
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
7/01/2020
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
6/01/2025
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Actual
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Sample size
Target
500
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW
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Recruitment hospital [1]
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Westmead Hospital - Sydney
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Recruitment hospital [2]
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Blacktown Hospital - Sydney
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Recruitment hospital [3]
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Nepean Hospital - Sydney
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Recruitment postcode(s) [1]
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2145 - Sydney
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Recruitment postcode(s) [2]
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2148 - Sydney
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Recruitment postcode(s) [3]
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2747 - Sydney
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Funding & Sponsors
Primary sponsor type
Other
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Name
Western Sydney Local Health District
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Address
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Country
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Other collaborator category [1]
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Other
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Name [1]
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University of Western Sydney
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Address [1]
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Country [1]
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Ethics approval
Ethics application status
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Summary
Brief summary
Immune-checkpoint inhibitors have recently become available as a new therapy for a variety of cancers. This drugs function by boosting the anti-cancer immune response, but unfortunately, may cause off-target, non-specific immune activation, resulting in liver and gut toxicity. In order to understand the development of liver immune-related adverse events we aim to collect full clinicopathological data from patients with advanced lung cancer treated with immune-checkpoint inhibitors at Blacktown, Westmead and Nepean Hospitals. Patients treated with standard chemotherapy will be used as a control group. This study aims to establish clinical risk factors that can predict the occurrence of liver immune-related adverse events in patients with advanced lung cancer treated with immune-checkpoint inhibitors. Such predictors may assist in the stratification of patients based on their risk for development liver toxicity as a result of immunotherapy, allowing early cessation/modification of treatment prior to the development of severe adverse reactions. In addition, this retrospective study will aim to determine the significance of pre-existing liver damage on the development of liver adverse events as well as establish a timeline defining the development of adverse events in the liver.
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Trial website
https://clinicaltrials.gov/study/NCT04595734
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Golo Ahlenstiel, Professor
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Address
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Blacktown Hospital, Western Sydney Local Health District
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Golo Ahlenstiel, Professor
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Address
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Country
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Phone
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+61 432 303 547
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Undecided
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No/undecided IPD sharing reason/comment
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT04595734