Exosomes Implication in PD1-PD-L1 Activation in OSAS (ExoSAS)

February 9, 2023 updated by: University Hospital, Angers

Exosomes Implication in PD1-PD-L1 Pathway Activation in Obstructive Sleep Apnea Syndrome

An increased occurrence of cancer associated mortality has been described in patients with Obstructive Sleep Apnea Syndrome (OSAS). This association might be partially explained by an impaired cellular immune response that has been described in OSAS. Is has been suggested that OSAS impact immune cells by upregulation of the PD-1/PD-L1 pathway. Exosomes are small membrane vesicles released by numerous cells in the bloodstream. Exosomes have been shown to be implicated in cancer cells proliferation via a PD-1/PD-L1 pathway activation.

This study will evaluate exosomal PD-1/PD-L1 expression in patients with OSAS as compared to controls and will further investigate their impact on immune cells function and proliferation capacities.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

90

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
      • Angers, France, 49100
        • Laboratoire du Sommeil, Département de Pneumologie, CHU d'Angers

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

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients investigated by sleep recording for suspected OSAS will be included in the study.

Description

Inclusion Criteria:

  • Patients requiring a sleep recording for suspected OSAS

Exclusion Criteria:

  • Préviously treated OSAS
  • Cancer past history
  • Pregnant women
  • Cognitif impairment

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
OSAS patients
45 patients investigated for suspected OSAS with an apnea hypopnea index ≥15 per hour
Diagnostic test: PD1/PD-L1 exosomal expression
exosomal PD1/PD-L1 expression
Non OSAS patients
45 patients investigated for suspected OSAS with an apnea hypopnea index <15 per hour
Diagnostic test: PD1/PD-L1 exosomal expression
exosomal PD1/PD-L1 expression

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
exosomal PD1 expression
Time Frame: at baseline
Peripheral blood (≈20 ml) will be collected from non-OSAS or OSAS subjects on EDTA-coated tubes. Exosomes will be isolated by centrifugation. For detecting exosome-associated surface proteins by flow cytometry, exosomes will be first captured on magnetic beads. The bead/exosome complexes will be then co-incubated with the labeled detection antibodies, either anti-PD1. Next, the complexes will be washed 3x resuspended in 300uL of PBS for antigen detection by flow cytometry.
at baseline
exosomal PD-L1 expression
Time Frame: at baseline
Peripheral blood (≈20 ml) will be collected from non-OSAS or OSAS subjects on EDTA-coated tubes. Exosomes will be isolated by centrifugation. For detecting exosome-associated surface proteins by flow cytometry, exosomes will be first captured on magnetic beads. The bead/exosome complexes will be then co-incubated with the labeled detection antibodies, either anti-PD-L1. Next, the complexes will be washed 3x resuspended in 300uL of PBS for antigen detection by flow cytometry.
at baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Angers

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)

March 3, 2019

Primary Completion (ACTUAL)

October 14, 2020

Study Completion (ACTUAL)

October 14, 2020

Study Registration Dates

First Submitted

January 15, 2019

First Submitted That Met QC Criteria

January 18, 2019

First Posted (ACTUAL)

January 22, 2019

Study Record Updates

Last Update Posted (ACTUAL)

February 10, 2023

Last Update Submitted That Met QC Criteria

February 9, 2023

Last Verified

May 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2019-A00029-48

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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