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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03811600
Other study ID # 2019-A00029-48
Secondary ID
Status Completed
Phase
First received
Last updated
Start date March 3, 2019
Est. completion date October 14, 2020

Study information

Verified date May 2022
Source University Hospital, Angers
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 90
Est. completion date October 14, 2020
Est. primary completion date October 14, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Patients requiring a sleep recording for suspected OSAS Exclusion Criteria: - Préviously treated OSAS - Cancer past history - Pregnant women - Cognitif impairment

Study Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
PD1/PD-L1 exosomal expression
exosomal PD1/PD-L1 expression

Locations

Country Name City State
France Laboratoire du Sommeil, Département de Pneumologie, CHU d'Angers Angers

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Angers

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary exosomal PD1 expression 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
Primary exosomal PD-L1 expression 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
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