Ignite Creation Date:
2024-05-06 @ 3:44 PM
Last Modification Date:
2024-10-26 @ 1:55 PM
Study NCT ID:
NCT04734067
Status:
NOT_YET_RECRUITING
Last Update Posted:
2021-08-23
First Post:
2021-01-12
Brief Title:
Exploration of the Predictive Marker and Establishment of Predictive Models of Checkpoint Inhibitor Pneumonitis
Sponsor:
First Affiliated Hospital Xian Jiaotong University
Organization:
First Affiliated Hospital Xian Jiaotong University
Study Overview
Official Title:
Exploration of Predictive Markers and Establishment of Predictive Models for Checkpoint Inhibitor Pneumonitis in Combination With Imaging in Immune Checkpoint Inhibitor Therapy
Status:
NOT_YET_RECRUITING
Status Verified Date:
2021-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a prospective multicenter observational study to explore the predictive factors of checkpoint inhibitor pneumonitis CIP and to establish predictive models by combining imaging information for IRP The imaging type of CIP the pathological type various inflammatory cytokines and tumor proportion scoreTPS of PD-L1 expression level etc will be paid more attention
Detailed Description:
Prospective dual-arm multicenter observational study to explore the predictive factors of checkpoint inhibitor pneumonitis CIP and to establish predictive models by combining imaging informationPatients will receive work-up treatment and follow-up exclusively as routinely done except monitoring and evaluation of CIP Necessary tests will be required such as lung function tests lymphocyte subsets and thin-section CT of the chest during evaluation of the diseaseThis study mainly included patients with malignant tumor who received immune checkpoint inhibitors for the first timeFasting venous blood was taken before treatment and before cycle 352n1 of treatment Then the blood samples were centrifuged and frozen in a refrigerator at -80 for later mass spectrometry analysis IrAEs of patients was strictly recorded according to CommonTerminology Criteria Adverse Events V40 CTCAE V40 The main objective was to explore the relationship between various indicators and the occurrence of CIP including pulmonary ventilation and diffusion function at baseline C-reative proteinCRP cytokines interleukin-6IL-6 CD4 T lymphocyte count and percentage CD8 T lymphocyte count and percentage NK cell count and percentage total T lymphocyte count and percentage neutrophil counts and percentages eosinophilic cell count and percentage white blood cell count blood platelet count serum albuminALB alanine aminotransferaseALT aspartate aminotransferase AST γ-glutamyl transpeptadaseγ-GGT body mass index BMI serum procalcitoninPCT smoking index and various inflammatory cytokines
Primary study endpoints The predictive factors and the predictive models of CIP
Secondary study endpoints The incidence and clinical characteristics of CIP
Primary study endpoints The predictive factors and the predictive models of CIP
Secondary study endpoints The incidence and clinical characteristics of CIP
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None