irAE Prediction of Anti-PD-1/L1 in Lung Cancer

Immunological Biomarkers for Immune-related Adverse Events of Anti-PD-1/PD-L1 Immunotherapy in Lung Cancer: a Prediction Model

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05288569

Enrollment

120

Registered

2022-03-21

Start date

2022-01-21

Completion date

2024-09-30

Last updated

2023-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Immune Checkpoint Inhibitors, Lung Cancer

Keywords

immunology, biomarkers, prediction, multidimensional

Brief summary

the purpose of this study is to identify multi-dimensional immunological biomarkers including cytokines, autoantibodies, and immune cell subtypes of immune-related adverse events (primary) and prognosis(secondary) in the anti-PD-1/anti-PD-L1 immunotherapy for lung cancer

Detailed description

After being informed of the study and potential risk, all patients giving written informed consent will undergo peripheral blood sample collection at baseline (before treatment ), 1month and 3month after treatment initiation, and when immune-related adverse events ever occur. The follow-up period will be 1 year for any occurrence of immune-related adverse events and 2 years follow-up for the prognosis.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

Inclusion criteria

* 18-80 years of age * Stage I-IV Lung Cancer confirmed by histopathology or imaging techniques * Receiving anti-PD-1/anti-PD-L1 immunotherapy (with indication and no contraindication)

Exclusion criteria

* Other cancer treatment * Other malignancies

Design outcomes

Primary

Measure	Time frame	Description
occurrence of immune-related adverse event (irAE)	12 months since immunotherapy initiation	Any adverse events occured within 12 months since immunotherapy initiation will be independently evaluated by two clinicians to determine whether it is irAE and all the clinical characteristics of irAE will be documented

Secondary

Measure	Time frame	Description
Overall Survival	24 months since immunotherapy initiation	Patients will be followed up for 2 years to investigate Overall Survival
Progression Free Survival.	24 months since immunotherapy initiation	Patients will be followed up for 2 years to investigate Progression Free Survival.

Countries

China

Contacts

Primary ContactHuaxia Yang

yanghuaxia2013@163.com+86-13488869596

Outcome results