NCT04609930

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
143

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 26, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 30, 2020

Completed
Same day until next milestone

Study Start

First participant enrolled

October 30, 2020

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2021

Completed
Last Updated

December 23, 2021

Status Verified

November 1, 2021

Enrollment Period

10 months

First QC Date

October 26, 2020

Last Update Submit

December 22, 2021

Conditions

Patients Recieving Anti-PD-1 or Anti-PD-L1 Immunotherapies

Outcome Measures

Primary Outcomes (5)

  • Change in % eosinophilia after initiation of anti-PD-1 and/or anti-PD-L1

    Before treatment (before day 0) versus after (15 days)

  • Change in % eosinophilia after initiation of anti-PD-1 and/or anti-PD-L1

    Before treatment (before day 0) versus after (1 month)

  • Change in % eosinophilia after initiation of anti-PD-1 and/or anti-PD-L1

    Before treatment (before day 0) versus after (3 months)

  • Change in % eosinophilia after initiation of anti-PD-1 and/or anti-PD-L1

    Before treatment (before day 0) versus after (6 months)

  • Change in % eosinophilia after initiation of anti-PD-1 and/or anti-PD-L1

    Before treatment (before day 0) versus after (12 months)

Secondary Outcomes (3)

  • Indication leading to anti-PD-1 and/or anti-PD-L1 immunotherapies

    Day 0

  • Age (years)

    Day 0

  • Sex (male/female)

    Day 0

Study Arms (1)

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

Interventions

Anti-PD-1 or anti-PD-L1DRUG

Immunotherapy treatment via anti programmed death 1 and/or anti-programmed death ligand 1.

The study population

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • 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

You may not qualify if:

  • No mention of % eosinophilia in the patient file

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UH Montpellier

Montpellier, 34295, France

Location

Study Officials

  • Jeremy Charriot, MD

    University Hospital, Montpellier

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 26, 2020

First Posted

October 30, 2020

Study Start

October 30, 2020

Primary Completion

August 31, 2021

Study Completion

August 31, 2021

Last Updated

December 23, 2021

Record last verified: 2021-11

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)