Exosomes Implication in PD1-PD-L1 Activation in OSAS

Completed

• Conditions: Sleep Apnea Syndromes, Obstructive; Cancer
• Interventions: Diagnostic Test: PD1/PD-L1 exosomal expression

• Registration Number: NCT03811600
• Lead Sponsor: University Hospital, Angers

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-01-15
• Study First Submitted QC: 2019-01-18
• Study First Posted: 2019-01-22
• Study Start: 2019-03-03
• Primary Completion: 2020-10-14
• Study Completion: 2020-10-14
• Status Verified: 2022-05
• Last Update Submitted: 2023-02-09
• Last Update Posted: 2023-02-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

• Patients requiring a sleep recording for suspected OSAS

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Non OSAS patients	PD1/PD-L1 exosomal expression	45 patients investigated for suspected OSAS with an apnea hypopnea index \<15 per hour
OSAS patients	PD1/PD-L1 exosomal expression	45 patients investigated for suspected OSAS with an apnea hypopnea index ≥15 per hour

Primary Outcome Measures

Name	Time	Method
exosomal PD1 expression	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.
exosomal PD-L1 expression	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.

Trial Locations

Locations (1)

Laboratoire du Sommeil, Département de Pneumologie, CHU d'Angers; 🇫🇷 Angers, France