Sleep Apnea Syndromes, ObstructiveExoSASNCT03811600
Exosomes Implication in PD1-PD-L1 Activation in OSAS
An observational study of Sleep Apnea Syndromes, Obstructive and Cancer, run by University Hospital, Angers at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sleep Apnea Syndromes, Obstructive, Cancer
- What is being tested?
- PD1/PD-L1 exosomal expression
- How many people
- 90 participants
- Where
- 1 siteFrance
- Study dates
- 3 Mar 2019to 14 Oct 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients investigated by sleep recording for suspected OSAS will be included in the study.
Who may be able to join
- Patients requiring a sleep recording for suspected OSAS
Who cannot join
- Préviously treated OSAS
- Cancer past history
- Pregnant women
- Cognitif impairment
Trial locations and contacts
1 site in 1 country.
France1 site
Laboratoire du Sommeil, Département de Pneumologie, CHU d'Angers
Angers, 49100
About this study
Official title: 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.
- Conditions
- Sleep Apnea Syndromes, Obstructive, Cancer
- Being tested
- PD1/PD-L1 exosomal expression
- Medical subject headings
- Sleep Apnea Syndromes, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PD1/PD-L1 exosomal expressionDiagnostic test
exosomal PD1/PD-L1 expression
| Study group | Role | What they receive |
|---|---|---|
| OSAS patients | 45 patients investigated for suspected OSAS with an apnea hypopnea index ≥15 per hour Receives: Diagnostic Test: PD1/PD-L1 exosomal expression | |
| Non OSAS patients | 45 patients investigated for suspected OSAS with an apnea hypopnea index <15 per hour Receives: Diagnostic Test: PD1/PD-L1 exosomal expression |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: at baseline
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.
Measured: at baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2019
- Study start3 Mar 2019
- Primary completion14 Oct 2020
- Study completion14 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep Apnea Syndromes, ObstructiveStudies of the same condition, open and under way.
- More trials run by University Hospital, AngersThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Angers
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03811600
- Sponsor's protocol ID
- 2019-A00029-48
- Acronym
- ExoSAS
- Status last verified
- May 2022
- First submitted
- 15 Jan 2019
- Last updated
- 10 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exosomes Implication in PD1-PD-L1 Pathway Activation in Obstructive Sleep Apnea Syndrome
- ClinicalTrials.gov ID
- NCT03811600
- Acronym / sponsor ID
- ExoSAS / 2019-A00029-48
- Conditions
- Sleep Apnea Syndromes, Obstructive, Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- University Hospital, AngersOther government
- Study start
- 3 Mar 2019 (actual)
- Primary completion
- 14 Oct 2020 (actual)
- Study completion
- 14 Oct 2020 (actual)
- First posted
- 22 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| OSAS patients | – | Diagnostic Test: PD1/PD-L1 exosomal expression45 patients investigated for suspected OSAS with an apnea hypopnea index ≥15 per hour |
| Non OSAS patients | – | Diagnostic Test: PD1/PD-L1 exosomal expression45 patients investigated for suspected OSAS with an apnea hypopnea index <15 per hour |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients investigated by sleep recording for suspected OSAS will be included in the study.
Key inclusion criteria (1 listed)
- Patients requiring a sleep recording for suspected OSAS
Key exclusion criteria (4 listed)
- Préviously treated OSAS
- Cancer past history
- Pregnant women
- Cognitif impairment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PD1/PD-L1 exosomal expressionexosomal PD1/PD-L1 expression | Diagnostic test | Non OSAS patients, OSAS patients |
Primary outcome
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sleep Apnea Syndromes, Obstructive and Cancer, run by University Hospital, Angers at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
exosomal PD1 expression (time frame: at baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2023.