Ignite Creation Date:
2025-12-24 @ 4:18 PM
Ignite Modification Date:
2025-12-29 @ 11:11 AM
Study NCT ID:
NCT06702566
Status:
RECRUITING
Last Update Posted:
2024-11-25
First Post:
2024-07-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Serum Ferritin in irAE
Sponsor:
Tianjin Medical University Cancer Institute and Hospital
Organization:
Study Overview
Official Title:
The Significance of Serum Ferritin in the Diagnosis, Differential Diagnosis, and Prognosis of Immune-related Adverse Event (irAE)
Status:
RECRUITING
Status Verified Date:
2024-07
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 clinical study to clarify serum ferritin as a biomarker for the diagnosis, differential diagnosis and prognosis of immune-related adverse event(irAE).
Detailed Description:
A total of 1500 patients with definitive diagnosis of malignant solid tumor or acute leukemia will be enrolled in this study. Patients are divided into 3 groups according to the anti-tumor therapy they are to receive. Three groups will be set up, namely group A: immunotherapy group (patients will be treated with immunotherapy, or immuno- plus targeted therapy, or immuno- plus chemotherapy); group B: targeted therapy group (patients will be treated with targeted monotherapy, targeted plus chemotherapy); group C: chemotherapy group (patients will be treated with chemotherapy). All patients received blood biochemistry and imaging at baseline, and adverse events were monitored. If a patient in the immunotherapy group presents with an AE, the AE is diagnosed by a multi-disciplinary MDT team including oncologists, rheumatologists, immunologists, respiratory pathologists, radiologists, and pathologists, and further diagnosed as irAE or non-irAE. All patients underwent hematologic testing every 3 days (at least 3 times) after the onset of AE including: blood routine examination, ferritin, CRP, D-dimer, and cytokines (IL-1β, IL-6, and TNF-α)until recovery from AE. Patients without AE will re-testing of baseline blood biochemistry every 4 treatment cycles.
Study Oversight
Has Oversight DMC:
True
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?: