irAE Prediction of Anti-PD-1/L1 in Lung Cancer

NCT ID: NCT05288569

Last Updated: 2023-04-07

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

UNKNOWN

Total Enrollment

120 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-01-21

Study Completion Date

2024-09-30

Brief Summary

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the purpose of this study is to identify multi-dimensional immunological biomarkers including cytokines, autoantibodies, and immune cell subtypes of immune-related adverse events (primary) and prognosis(secondary) in the anti-PD-1/anti-PD-L1 immunotherapy for lung cancer

Detailed Description

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After being informed of the study and potential risk, all patients giving written informed consent will undergo peripheral blood sample collection at baseline (before treatment ), 1month and 3month after treatment initiation, and when immune-related adverse events ever occur. The follow-up period will be 1 year for any occurrence of immune-related adverse events and 2 years follow-up for the prognosis.

Conditions

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Immune Checkpoint Inhibitors Lung Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* 18-80 years of age
* Stage I-IV Lung Cancer confirmed by histopathology or imaging techniques
* Receiving anti-PD-1/anti-PD-L1 immunotherapy (with indication and no contraindication)

Exclusion Criteria

* Other cancer treatment
* Other malignancies
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Peking Union Medical College Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Huaxia Yang

Role: STUDY_CHAIR

Peking Union Medical College Hospital

Locations

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Peking Union Medical College Hospital

Beijing, , China

Site Status RECRUITING

Countries

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China

Central Contacts

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Huaxia Yang

Role: CONTACT

+86-13488869596

Facility Contacts

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Huaxia Yang

Role: primary

+86-13488869596

References

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Yang H, Yao Z, Zhou X, Zhang W, Zhang X, Zhang F. Immune-related adverse events of checkpoint inhibitors: Insights into immunological dysregulation. Clin Immunol. 2020 Apr;213:108377. doi: 10.1016/j.clim.2020.108377. Epub 2020 Mar 2.

Reference Type BACKGROUND
PMID: 32135278 (View on PubMed)

Other Identifiers

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JS-2853

Identifier Type: -

Identifier Source: org_study_id

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