Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 5:10 PM
Ignite Modification Date:
2025-12-24 @ 5:10 PM
NCT ID:
NCT06243250
Eligibility Criteria:
Inclusion Criteria
Patients undergoing ICIs:
1. Inform consent obtained.
2. Patients more than or equal to 20-year-old.
3. Patients developing IRAEs or not, including but not limited to the following events: colitis、endocrinopathy、hepatitis、pneumonitis、skin toxicity.
Healthy volunteers:
1. Inform consent obtained.
2. Patients more than or equal to 20-year-old.
Exclusion Criteria
Patients undergoing ICIs:
1. Life-threatening irAEs (CTCAE ≥ grade 4).
2. Abnormal spleen attributable to other diseases (e.g., liver cirrhosis related splenomegaly or primary/metastatic splenic tumors).
3. Pregnant or breast-feeding women.
4. Contraindication to MRI study (e.g., claustrophobia or non-removable devices or implants that are incompatible with MRI).
5. Intercurrent illness that will affect the compliance of the patient during the MRI study (e.g., active infection, symptomatic congestive heart failure, uncontrollable angina, arrhythmia, psychiatric disorders, dyspnea, or diarrhea).
6. Severe hepatic dysfunction (alkaline phosphatase/aspartate aminotransferase/alanine aminotransferase \>20 × upper limit of normal \[ULN\] or bilirubin \> 10 × ULN).
7. Severe renal impairment (eGFR \<30 ml/min/1.73m2).
Healthy volunteers:
1. Pregnant or breast-feeding women.
2. Contraindication to MRI study (e.g., claustrophobia or non-removable devices or implants that are incompatible with MRI).
3. Body mass index (BMI) \>35 kg/m2.
4. Significant clinical history of any kind, including but not limited to the following conditions: diabetes mellitus (DM), hypertension (HTN), heart disease, liver disease, kidney disease, blood disorders, immune system-related diseases, etc.
5. Need for medication due to any medical condition within the last 14 days.
6. History of substance abuse (e.g., alcoholism with blood alcohol concentration ≥0.08%).
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
20 Years
Study:
NCT06243250
Study Brief:
Protocol Section:
NCT06243250