- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03811600
Exosomes Implication in PD1-PD-L1 Activation in OSAS (ExoSAS)
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
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
-
Angers, France, 49100
- Laboratoire du Sommeil, Département de Pneumologie, CHU d'Angers
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
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
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
|
exosomal PD1/PD-L1 expression
|
|
Non OSAS patients
45 patients investigated for suspected OSAS with an apnea hypopnea index <15 per hour
|
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
Sponsor
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
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
Studies a U.S. FDA-regulated device product
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