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:
2025-12-25 @ 2:03 AM
Ignite Modification Date:
2025-12-25 @ 2:03 AM
NCT ID:
NCT07249060
Eligibility Criteria:
ICI cohort:
Inclusion Criteria:
* Initiation of treatment with a single ICI or dual ICI therapy in accordance with current clinical guidelines;
* Patients who are treatment-naïve to ICIs; and
* Age ≥18 years.
Exclusion Criteria:
* Estimated mortality of less than 3 months from the start of treatment;
* Current combination therapy with chemotherapy, tyrosine kinase inhibitors, or other tumor-specific treatments;
* Contraindication to treatment with ICIs (documented hypersensitivity, severe active autoimmune disease, Eastern Cooperative Oncology Group \[ECOG\] ≥3);
* Ongoing immunosuppressive therapy, including prednisone at doses \>10 mg/day or equivalent.
SAD cohort:
Inclusion Criteria:
* Meeting classification criteria for Systemic Lupus Erythematosus (SLE) (ACR/EULAR 2019), Primary Sjögren's Syndrome (pSS) (ACR/EULAR 2016), Systemic Sclerosis (SSc) (ACR/EULAR 2013), and/or Idiopathic Inflammatory Myopathy (IIM) (ACR/EULAR 2017).
* Age ≥18 years old.
Exclusion Criteria:
* Estimated mortality less than 3 months from the start of follow-up.
* Active immunosuppressive treatment, including prednisone at doses \>10 mg/day or equivalent.
* Recent diagnosis (\<1 year) of cancer, with the exception of non-melanoma skin cancer, or currently receiving active oncology-specific treatment.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT07249060
Study Brief:
Protocol Section:
NCT07249060