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Trial record 26 of 127 for:    exosomes

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

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ClinicalTrials.gov Identifier: NCT03811600
Recruitment Status : Not yet recruiting
First Posted : January 21, 2019
Last Update Posted : January 21, 2019
Sponsor:
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment
Sleep Apnea Syndromes, Obstructive Cancer Diagnostic Test: PD1/PD-L1 exosomal expression

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Study Type : Observational
Estimated Enrollment : 90 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: Exosomes Implication in PD1-PD-L1 Pathway Activation in Obstructive Sleep Apnea Syndrome
Estimated Study Start Date : March 1, 2019
Estimated Primary Completion Date : March 1, 2020
Estimated Study Completion Date : March 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sleep Apnea

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




Primary Outcome Measures :
  1. exosomal PD1 expression [ Time Frame: 1 hour ]
    Peripheral blood (≈20 ml) will be collected from non-OSAS or OSAS subjects on EDTA-coated tubes. After a 15-min centrifugation at 260×g, plasma will be separated from whole blood and further ultracentrifuged two times at 100,000×g for 1 h to isolate exosomes. 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.

  2. exosomal PD-L1 expression [ Time Frame: 1 hour ]
    Peripheral blood (≈20 ml) will be collected from non-OSAS or OSAS subjects on EDTA-coated tubes. After a 15-min centrifugation at 260×g, plasma will be separated from whole blood and further ultracentrifuged two times at 100,000×g for 1 h to isolate exosomes. 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.


Biospecimen Retention:   Samples Without DNA
Plasma and serum


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients investigated by sleep recording for suspected OSAS will be included in the study.
Criteria

Inclusion Criteria:

  • Patients requiring a sleep recording for suspected OSAS

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03811600


Contacts
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Contact: Wojciech Trzepizur, MD PhD +33680575272 ext +33 wotrzepizur@chu-angers.fr

Locations
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France
Laboratoire du Sommeil, Département de Pneumologie, CHU d'Angers
Angers, France, 49100
Sponsors and Collaborators
University Hospital, Angers

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Responsible Party: University Hospital, Angers
ClinicalTrials.gov Identifier: NCT03811600     History of Changes
Other Study ID Numbers: 2019-A00029-48
First Posted: January 21, 2019    Key Record Dates
Last Update Posted: January 21, 2019
Last Verified: January 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Syndrome
Disease
Pathologic Processes
Apnea
Respiration Disorders
Respiratory Tract Diseases
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases