- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04609930
Impact of Immune Checkpoint Inhibitor Therapy on Type 2 Inflammation (ImmunEO)
December 22, 2021 updated by: University Hospital, Montpellier
The primary objective of this study is to determine the impact of anti-checkpoint immunotherapy on type 2 inflammation via a retrospective analysis of % eosinophilia.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
143
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Montpellier, France, 34295
- UH Montpellier
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
The study population corresponds to all patients within the University Hospitals of Montpellier system who received anti-PDF-1 and/or anti-PD-L1 immunotherapies.
Description
Inclusion Criteria:
- Electronic patient file "DxCare" at the University Hospitals of Montpellier
- Patient has received anti-PD-1 immunotherapy --AND/OR -- anti-PD-L1 immunotherapy according to central pharmacy records
Exclusion Criteria:
- No mention of % eosinophilia in the patient file
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
The study population
Patients in the University Hospitals of Montpellier system who have received anti-PD-1 and/or anti-PD-L1
|
Immunotherapy treatment via anti programmed death 1 and/or anti-programmed death ligand 1.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change in % eosinophilia after initiation of anti-PD-1 and/or anti-PD-L1
Time Frame: Before treatment (before day 0) versus after (15 days)
|
Before treatment (before day 0) versus after (15 days)
|
Change in % eosinophilia after initiation of anti-PD-1 and/or anti-PD-L1
Time Frame: Before treatment (before day 0) versus after (1 month)
|
Before treatment (before day 0) versus after (1 month)
|
Change in % eosinophilia after initiation of anti-PD-1 and/or anti-PD-L1
Time Frame: Before treatment (before day 0) versus after (3 months)
|
Before treatment (before day 0) versus after (3 months)
|
Change in % eosinophilia after initiation of anti-PD-1 and/or anti-PD-L1
Time Frame: Before treatment (before day 0) versus after (6 months)
|
Before treatment (before day 0) versus after (6 months)
|
Change in % eosinophilia after initiation of anti-PD-1 and/or anti-PD-L1
Time Frame: Before treatment (before day 0) versus after (12 months)
|
Before treatment (before day 0) versus after (12 months)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Indication leading to anti-PD-1 and/or anti-PD-L1 immunotherapies
Time Frame: Day 0
|
Name of pathology
|
Day 0
|
Age (years)
Time Frame: Day 0
|
Day 0
|
|
Sex (male/female)
Time Frame: Day 0
|
Day 0
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 30, 2020
Primary Completion (Actual)
August 31, 2021
Study Completion (Actual)
August 31, 2021
Study Registration Dates
First Submitted
October 26, 2020
First Submitted That Met QC Criteria
October 26, 2020
First Posted (Actual)
October 30, 2020
Study Record Updates
Last Update Posted (Actual)
December 23, 2021
Last Update Submitted That Met QC Criteria
December 22, 2021
Last Verified
November 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- RECHMPL20_0583
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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