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

Conditions

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

  • France
      • 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
Drug: Anti-PD-1 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

University Hospital, Montpellier

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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