Immune Checkpoint InhibitorsNCT05288569
irAE Prediction of Anti-PD-1/L1 in Lung Cancer
An observational study of Immune Checkpoint Inhibitors and Lung Cancer, run by Peking Union Medical College Hospital at 1 site in China.
Trial summary
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 Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Immune Checkpoint Inhibitors, Lung Cancer
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 21 Jan 2022to Sep 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients at a national tertiary referral center for lung cancer treatment
Who may be able to join
- 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)
Who cannot join
- Other cancer treatment
- Other malignancies
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Peking Union Medical College Hospital
Beijing
Huaxia Yang, +86-13488869596, yanghuaxia2003@163.com
About this study
Official title: Immunological Biomarkers for Immune-related Adverse Events of Anti-PD-1/PD-L1 Immunotherapy in Lung Cancer: a Prediction Model
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
Read the detailed description
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
- Immune Checkpoint Inhibitors, Lung Cancer
- Keywords
- immunology, biomarkers, prediction, multidimensional
- Medical subject headings
- Lung Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
occurrence of immune-related adverse event (irAE)
Any adverse events occured within 12 months since immunotherapy initiation will be independently evaluated by two clinicians to determine whether it is irAE and all the clinical characteristics of irAE will be documented
Measured: 12 months since immunotherapy initiation
Secondary outcomes (2)
Overall Survival
Patients will be followed up for 2 years to investigate Overall Survival
Measured: 24 months since immunotherapy initiation
Progression Free Survival.
Patients will be followed up for 2 years to investigate Progression Free Survival.
Measured: 24 months since immunotherapy initiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2022
- Study start21 Jan 2022
- Primary completionSep 2023 (estimated)
- Study completionSep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Immune Checkpoint InhibitorsStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Huaxia Yang, Study chair, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05288569
- Sponsor's protocol ID
- JS-2853
- Status last verified
- Mar 2023
- First submitted
- 11 Mar 2022
- Last updated
- 7 Apr 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 32135278
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immunological Biomarkers for Immune-related Adverse Events of Anti-PD-1/PD-L1 Immunotherapy in Lung Cancer: a Prediction Model
- ClinicalTrials.gov ID
- NCT05288569
- Acronym / sponsor ID
- JS-2853
- Conditions
- Immune Checkpoint Inhibitors, Lung Cancer
- Keywords
- immunology, biomarkers, prediction, multidimensional
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- 21 Jan 2022 (actual)
- Primary completion
- Sep 2023 (estimated)
- Study completion
- Sep 2024 (estimated)
- First posted
- 21 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients at a national tertiary referral center for lung cancer treatment
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (2 listed)
- Other cancer treatment
- Other malignancies
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
occurrence of immune-related adverse event (irAE)
Time frame: 12 months since immunotherapy initiation
Any adverse events occured within 12 months since immunotherapy initiation will be independently evaluated by two clinicians to determine whether it is irAE and all the clinical characteristics of irAE will be documented
2 secondary outcomes
Overall Survival
Time frame: 24 months since immunotherapy initiation
Progression Free Survival.
Time frame: 24 months since immunotherapy initiation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2023.
- Background: PubMed 32135278Yang 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Huaxia Yang study chair
Peking Union Medical College Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Immune Checkpoint Inhibitors and Lung Cancer, run by Peking Union Medical College Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Huaxia Yang (+86-13488869596, yanghuaxia2013@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
occurrence of immune-related adverse event (irAE) (time frame: 12 months since immunotherapy initiation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05288569, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2023.