HEPATICI: Clinical Significance of Hepatic Biomarkers in Lung Cancer Patients Treated With Immune Checkpoint Inhibitors

Sponsor

Centre Hospitalier Universitaire, Amiens (Other)

Overall Status

Recruiting

CT.gov ID

NCT05653531

Collaborator

(none)

110

Enrollment

Location

11.2

Anticipated Duration (Months)

9.8

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Immune Checkpoint Inhibitor Lung Cancer Liver Biomarkers Transaminases	Other: Blood sample	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

110 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Other

Official Title:

Significance of Hepatic Biomarkers in the Evaluation of Response to Treatment and Prognosis in Lung Cancer Patients Treated With Immune Checkpoint Inhibitors

Actual Study Start Date :

Oct 25, 2022

Anticipated Primary Completion Date :

Apr 1, 2023

Anticipated Study Completion Date :

Oct 1, 2023

Outcome Measures

Primary Outcome Measures

basal ALT blood concentration in lung cancer patients treated with ICI determined [one year]
To Identify baseline blood ALT concentration as a predictive liver biomarker of treatment response in lung cancer patients treated with ICI.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CHU Amiens	Amiens		France	80054

Sponsors and Collaborators

Centre Hospitalier Universitaire, Amiens

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Centre Hospitalier Universitaire, Amiens

ClinicalTrials.gov Identifier:

NCT05653531

Other Study ID Numbers:

PI2021_843_0230

First Posted:

Dec 16, 2022

Last Update Posted:

Dec 16, 2022

Last Verified:

Oct 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Centre Hospitalier Universitaire, Amiens

immune checkpoint inhibitor

Lung Cancer

liver biomarkers

transaminases

Additional relevant MeSH terms:

Lung Neoplasms

Study Results

No Results Posted as of Dec 16, 2022