A Prospective Study to Observe Adverse Effects in Patients Receiving Anti-PD1 Immunotherapy

Study Overview
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Brief Summary
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The goal of this observational study is to learn about in the development process of adverse reactions of anti-PD1 immunotherapy. The main question it aims to observe: The autoantibody profile of patients The adverse reactions of patients The changes of immune cells and cytokine in patients

Detailed Description
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The goal of this observational study is to learn about the development process of adverse reactions of anti-PD1 immunotherapy. The main question it aims to observe: The autoantibody profile of patients The adverse reactions of patients The changes of immune cells and cytokine in patients (e.g., T cell, B cell, IL-6, etc.)

Official Title
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A Prospective Study to Observe Adverse Effects in Patients Receiving Anti-PD1 Immunotherapy

Conditions
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Immunotherapy, ADR

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥ 18 years old. Receiving anti-PD1 immunotherapy Exclusion Criteria: Vital signs are unstable Functional impairment of immune system caused by other diseases or other reasons, such as Systemic lupus erythematosus (SLE), AIDS, etc.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Autoantibodies | Including autoantibodies in Autoimmune encephalitis (NMDAR, AMPA1, AMPA2, CASPR2, GABABR, DPPX, IgLON5 and LGI1), myasthenia gravis (Including AChR, MuSK, LRP4, RyR, Titin), paraneoplastic neurologic syndromes (Hu, Yo, Ri, CV2, PNMA2, Amphiphysin, Recoverin, SOX1, Titin, Zic4, GAD65, Tr) and against gangliosides (GM1, GM2, GM3, GM4, GD1a, GD1b, GD2, GD3, GT1a, GT1b, GQ1b, Sulfatides). Cell transfection, ELISpot and ELISA are designed to be used. | Day 1 | 
| Autoantibodies | Including autoantibodies in Autoimmune encephalitis (NMDAR, AMPA1, AMPA2, CASPR2, GABABR, DPPX, IgLON5 and LGI1), myasthenia gravis (Including AChR, MuSK, LRP4, RyR, Titin), paraneoplastic neurologic syndromes (Hu, Yo, Ri, CV2, PNMA2, Amphiphysin, Recoverin, SOX1, Titin, Zic4, GAD65, Tr) and against gangliosides (GM1, GM2, GM3, GM4, GD1a, GD1b, GD2, GD3, GT1a, GT1b, GQ1b, Sulfatides). Cell transfection, ELISpot and ELISA are designed to be used. | Week 9 | 
| Autoantibodies | Including autoantibodies in Autoimmune encephalitis (NMDAR, AMPA1, AMPA2, CASPR2, GABABR, DPPX, IgLON5 and LGI1), myasthenia gravis (Including AChR, MuSK, LRP4, RyR, Titin), paraneoplastic neurologic syndromes (Hu, Yo, Ri, CV2, PNMA2, Amphiphysin, Recoverin, SOX1, Titin, Zic4, GAD65, Tr) and against gangliosides (GM1, GM2, GM3, GM4, GD1a, GD1b, GD2, GD3, GT1a, GT1b, GQ1b, Sulfatides). Cell transfection, ELISpot and ELISA are designed to be used. | Week 21 | 
| Autoantibodies | Including autoantibodies in Autoimmune encephalitis (NMDAR, AMPA1, AMPA2, CASPR2, GABABR, DPPX, IgLON5 and LGI1), myasthenia gravis (Including AChR, MuSK, LRP4, RyR, Titin), paraneoplastic neurologic syndromes (Hu, Yo, Ri, CV2, PNMA2, Amphiphysin, Recoverin, SOX1, Titin, Zic4, GAD65, Tr) and against gangliosides (GM1, GM2, GM3, GM4, GD1a, GD1b, GD2, GD3, GT1a, GT1b, GQ1b, Sulfatides). Cell transfection, ELISpot and ELISA are designed to be used. | Week 33 | 
| Autoantibodies | Including autoantibodies in Autoimmune encephalitis (NMDAR, AMPA1, AMPA2, CASPR2, GABABR, DPPX, IgLON5 and LGI1), myasthenia gravis (Including AChR, MuSK, LRP4, RyR, Titin), paraneoplastic neurologic syndromes (Hu, Yo, Ri, CV2, PNMA2, Amphiphysin, Recoverin, SOX1, Titin, Zic4, GAD65, Tr) and against gangliosides (GM1, GM2, GM3, GM4, GD1a, GD1b, GD2, GD3, GT1a, GT1b, GQ1b, Sulfatides). Cell transfection, ELISpot and ELISA are designed to be used. | Week 45 | 
| the change of immune-related adverse events | Including polyradiculopathies, neuropathies, myasthenic syndromes, myopathies, hypophysitis, aseptic meningitis, encephalitis, multiple sclerosis and other complications. | baseline to Week 45 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the immune cell (Including T cell, B cell, etc.) | Including T cell, B cell, etc. Using flow cytometry | Day 1 | 
| the immune cell (Including T cell, B cell, etc.) | Using flow cytometry | Week 9 | 
| the immune cell (Including T cell, B cell, etc.) | Using flow cytometry | Week 21 | 
| the immune cell (Including T cell, B cell, etc.) | Using flow cytometry | Week 33 | 
| the immune cell (Including T cell, B cell, etc.) | Using flow cytometry | Week 45 | 
| the cytokine | Including IL-6, IL-17, etc. | Day 1 | 
| the cytokine | Including IL-6, IL-17, etc. | Week 9 | 
| the cytokine | Including IL-6, IL-17, etc. | Week 21 | 
| the cytokine | Including IL-6, IL-17, etc. | Week 33 | 
| the cytokine | Including IL-6, IL-17, etc. | Week 45 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PD1, immunotherapy