Actively Recruiting
The Effect of Serum Ferritin in irAE
Led by Tianjin Medical University Cancer Institute and Hospital · Updated on 2024-11-25
1500
Participants Needed
1
Research Sites
156 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
The Effect of Serum Ferritin in irAE
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients aged 18 to 75 years
- Patients of any gender
- Patients with a confirmed diagnosis of malignant solid tumor or acute leukemia
- Patients planned to receive immunotherapy (alone or combined), targeted therapy (alone or combined), or chemotherapy
- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
- Sufficient bone marrow function with neutrophil count > 1.5 x 10^9/L, lymphocyte count ≥ 0.3 x 10^9/L, platelets ≥ 100 x 10^9/L, hemoglobin ≥ 100 g/L
- Appropriate organ function including liver enzymes, bilirubin, creatinine, lung reserve, and coagulation within specified limits
- Negative urine pregnancy test for women of childbearing age and agreement to use effective contraception during and 1 year after the study
You will not qualify if you...
- Active systemic autoimmune disease under treatment before screening
- Stopped systemic hormone therapy less than 2 weeks before enrollment
- Prior organ or tissue transplantation
- Positive tests for hepatitis B surface antigen or e antigen, or high HBV-DNA levels
- Positive hepatitis C antibody
- Positive syphilis antibody
- Positive HIV antibody test
- Elevated EBV-DNA or CMV-DNA levels above measurable limits
- Heart conditions including left ventricular ejection fraction ≤ 50%, NYHA class III or IV heart failure, uncontrolled hypertension or pulmonary hypertension, recent myocardial infarction or cardiac surgery within 12 months, clinically significant valvular disease
- Clinical emergencies requiring urgent treatment due to tumor obstruction
- Active bleeding during screening
- Deep vein thrombosis or pulmonary embolism within 6 months before screening
- Received live vaccine within 6 weeks before screening
- Active infection needing treatment during screening
- Poor compliance
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin Municipality, China, 300060
Actively Recruiting
Research Team
L
Liang Liu, M.D
CONTACT
X
Xiubao Ren, M.D, Ph.D
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
DIAGNOSTIC
Number of Arms
3
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here