Clinical Significance of Hepatic Biomarkers in Lung Cancer Patients Treated With Immune Checkpoint Inhibitors (HEPATICI)
Primary Purpose
Immune Checkpoint Inhibitor, Lung Cancer, Liver Biomarkers
Status
Withdrawn
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Blood sample
Sponsored by
About this trial
This is an interventional other trial for Immune Checkpoint Inhibitor focused on measuring immune checkpoint inhibitor, Lung Cancer, liver biomarkers, transaminases
Eligibility Criteria
Inclusion Criteria: Inclusion criteria: Age > 18 years Patient with lung cancer of any histological type Initiation of ICI therapy Signed consent for the study Exclusion Criteria: Patient with previous ICI treatment
Sites / Locations
- CHU Amiens
Outcomes
Primary Outcome Measures
basal ALT blood concentration in lung cancer patients treated with ICI determined
To Identify baseline blood ALT concentration as a predictive liver biomarker of treatment response in lung cancer patients treated with ICI.
Secondary Outcome Measures
Full Information
NCT ID
NCT05653531
First Posted
December 8, 2022
Last Updated
July 18, 2023
Sponsor
Centre Hospitalier Universitaire, Amiens
1. Study Identification
Unique Protocol Identification Number
NCT05653531
Brief Title
Clinical Significance of Hepatic Biomarkers in Lung Cancer Patients Treated With Immune Checkpoint Inhibitors
Acronym
HEPATICI
Official Title
Significance of Hepatic Biomarkers in the Evaluation of Response to Treatment and Prognosis in Lung Cancer Patients Treated With Immune Checkpoint Inhibitors
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Withdrawn
Why Stopped
no participants enrolled
Study Start Date
October 25, 2022 (Actual)
Primary Completion Date
April 1, 2023 (Actual)
Study Completion Date
July 1, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire, Amiens
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Lung cancer is the leading cause of cancer death worldwide. The emergence of immune checkpoint inhibitors (ICIs) has revolutionized the treatment of lung cancer over the past 10 years. Nivolumab, ipilimumab, pembrolizumab, atezolizumab, and durvalumab have been successively approved in non-small cell lung cancer, small cell lung cancer, and pleural mesothelioma. Although the efficacy of ICIs is remarkable in some patients, the objective response rate is only about 20%. The development of predictive biomarkers for treatment response is essential. Non-invasive methods and easily accessible biomarkers at low cost are required.ICIs activate the immune system through the inhibition of checkpoints (PD-L1, PD-1). The immune system and the liver are interconnected and constantly interact through a complex regulatory system. Patients with lung cancer frequently suffer from liver damage, due to metastases, treatments or underlying pathologies. The objective of the study is to evaluate the clinical significance of key liver biomarkers (AST, ALT, PAL, GGT, bilirubin, PT) in patients with lung cancer treated with ICI.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Immune Checkpoint Inhibitor, Lung Cancer, Liver Biomarkers, Transaminases
Keywords
immune checkpoint inhibitor, Lung Cancer, liver biomarkers, transaminases
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
ParticipantInvestigator
Allocation
N/A
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Other
Intervention Name(s)
Blood sample
Intervention Description
Liver blood tests (AST, ALT, PAL, GGT, bilirubin, PT) will be performed before each ICI injection during the first three injections and again at 6 months.
Primary Outcome Measure Information:
Title
basal ALT blood concentration in lung cancer patients treated with ICI determined
Description
To Identify baseline blood ALT concentration as a predictive liver biomarker of treatment response in lung cancer patients treated with ICI.
Time Frame
one year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Inclusion criteria:
Age > 18 years
Patient with lung cancer of any histological type
Initiation of ICI therapy
Signed consent for the study
Exclusion Criteria:
Patient with previous ICI treatment
Facility Information:
Facility Name
CHU Amiens
City
Amiens
ZIP/Postal Code
80054
Country
France
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Clinical Significance of Hepatic Biomarkers in Lung Cancer Patients Treated With Immune Checkpoint Inhibitors
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