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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT04595734




Registration number
NCT04595734
Ethics application status
Date submitted
14/10/2020
Date registered
20/10/2020
Date last updated
13/11/2020

Titles & IDs
Public title
Liver Toxicity in Lung Cancer Patients Treated With Immune-checkpoint Inhibitors.
Scientific title
A Retrospective Study of Clinical Outcomes and Liver-related Toxicity of Patients With Lung Cancer Treated With Immune-checkpoint Inhibitors
Secondary ID [1] 0 0
2019/PID14816
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Lung Cancer Stage IV 0 0
Lung Cancer, Non-small Cell 0 0
Hepatitis 0 0
Condition category
Condition code
Cancer 0 0 0 0
Lung - Mesothelioma
Cancer 0 0 0 0
Lung - Non small cell
Cancer 0 0 0 0
Lung - Small cell

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
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

Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of participants with immune-mediated hepatitis
Timepoint [1] 0 0
Week 6-12 from treatment commencement
Primary outcome [2] 0 0
Baseline risk factors significantly correlated with hepatic immune-related adverse events - Blood test results, BMI, FibroScan data will be correlated with the development of liver toxicity
Timepoint [2] 0 0
Week 0
Secondary outcome [1] 0 0
Number of participants with non-hepatic immune-related adverse events
Timepoint [1] 0 0
Week 3-32 from treatment commencement
Secondary outcome [2] 0 0
Baseline risk factors significantly correlated with non-hepatic immune-related adverse events - Blood test results and BMI will be correlated with the development of immune-related adverse events (non-hepatic)
Timepoint [2] 0 0
Week 0

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
Minimum age
No limit
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. - Radiologically reported liver metastases

2. - Concurrent treatment with both therapeutic regimes

Study design
Purpose
Duration
Selection
Timing
Retrospective
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Westmead Hospital - Sydney
Recruitment hospital [2] 0 0
Blacktown Hospital - Sydney
Recruitment hospital [3] 0 0
Nepean Hospital - Sydney
Recruitment postcode(s) [1] 0 0
2145 - Sydney
Recruitment postcode(s) [2] 0 0
2148 - Sydney
Recruitment postcode(s) [3] 0 0
2747 - Sydney

Funding & Sponsors
Primary sponsor type
Other
Name
Western Sydney Local Health District
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
University of Western Sydney
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/show/NCT04595734
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Golo Ahlenstiel, Professor
Address 0 0
Blacktown Hospital, Western Sydney Local Health District
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Golo Ahlenstiel, Professor
Address 0 0
Country 0 0
Phone 0 0
+61 432 303 547
Fax 0 0
Email 0 0
Golo.Ahlenstiel@health.nsw.gov.au
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT04595734