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

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05669638

Enrollment

Registered

2023-01-03

Start date

2023-05-01

Completion date

2025-05-01

Last updated

2024-02-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

ADR, Immunotherapy

Keywords

PD1, immunotherapy

Brief summary

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

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.)

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

1. Age ≥ 18 years old. 2. Receiving anti-PD1 immunotherapy

Exclusion criteria

1. Vital signs are unstable 2. Functional impairment of immune system caused by other diseases or other reasons, such as Systemic lupus erythematosus (SLE), AIDS, etc.

Design outcomes

Primary

Measure	Time frame	Description
Autoantibodies	Day 1	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.
the change of immune-related adverse events	baseline to Week 45	Including polyradiculopathies, neuropathies, myasthenic syndromes, myopathies, hypophysitis, aseptic meningitis, encephalitis, multiple sclerosis and other complications.

Secondary

Measure	Time frame	Description
the immune cell (Including T cell, B cell, etc.)	Day 1	Including T cell, B cell, etc. Using flow cytometry
the cytokine	Day 1	Including IL-6, IL-17, etc.

Countries

China

Contacts

Primary ContactHongyan Li

hongyanli09@126.com18600346925

Backup Contactyanting zhou

2906066696@qq.com18055074535

Outcome results