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

NCT ID: NCT05669638

Last Updated: 2024-02-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

80 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-05-01

Study Completion Date

2025-05-01

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.)

Conditions

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Immunotherapy ADR

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Xuanwu Hospital, Beijing

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Hongyan Li, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

Xuanwu Hospital, Beijing

Locations

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Xuanwu Hospital

Beijing, Beijing Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Hongyan Li

Role: CONTACT

18600346925

yanting zhou

Role: CONTACT

18055074535

Facility Contacts

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Hongyan Li

Role: primary

18600346925

Other Identifiers

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hongyanli1

Identifier Type: -

Identifier Source: org_study_id

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