Bronchial CancerNEOSASNCT02648087
Prevalence of Sleep-disordered Breathing in Patients With a Newly Diagnosed Non Small Cell Lung Cancer
A study testing With and without SDB in people with Bronchial Cancer, run by University Hospital, Angers.
Trial summary
There is a possible implication of sleep apnea syndrome via night-time intermittent hypoxemia in perturbation of quality of life and tumour progression to patients with a bronchial cancer. The aim of the study is to evaluate this possibility with the help of a night record of sleep and quality of life questionnaires. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Bronchial Cancer
- What is being tested?
- With and without SDB
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,200 participants
- Where
- No sites listed yet
- Study dates
- Jan 2016to Nov 2018
- Phase
- Interventional
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients with NSCLC undergoing diagnostic
- Performance status 0,1,2
Who cannot join
- >75 years
- OSA known and in the last 12 months treated PS >2
- Patients under a long-term oxygen therapy
- persons deprived of liberty by judicial decision.
- <18 years
About this study
There is a possible implication of sleep apnea syndrome via night-time intermittent hypoxemia in perturbation of quality of life and tumour progression to patients with a bronchial cancer.
The aim of the study is to evaluate this possibility with the help of a night record of sleep and quality of life questionnaires.
Read the detailed description
There is a possible implication of sleep apnea syndrome via night-time intermittent hypoxemia in perturbation of quality of life and tumour progression to patients with a bronchial cancer.
Enrollment 1200 patients This wide sample is expected to respond to the main and secondary objectives of the study
- Conditions
- Bronchial Cancer
- Being tested
- With and without SDB
- Medical subject headings
- Carcinoma, Bronchogenic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
With and without SDBDevice
Screening of sleep-disordered breathing (SDB)
| Study group | Role | What they receive |
|---|---|---|
| With and without SDB | Other | comparison of patients with and without sleep-disordered breathing Receives: Device: With and without SDB |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oxygen desaturation index
RECORDING BY POLYGRAPHY DEVICE between day 1 and day 15 after enrollment
Measured: Between day 1 and day 15
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2016 (estimated)
- Study startJan 2016
- Primary completionNov 2018 (estimated)
- Study completionNov 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Bronchial CancerStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1,200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Angers
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02648087
- Sponsor's protocol ID
- 2015 -A00395 - 44
- Acronym
- NEOSAS
- Status last verified
- Dec 2015
- First submitted
- 27 Nov 2015
- Last updated
- 6 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Justeau G, Greillier L, Vinas F, Falchero L, Bylicki O, Bernardi M, Martin F, Simon I, Debieuvre D, Locher C, Bizieux-Thaminy A, Levrat V, Fry S, Guguen C, Goutorbe F, Masson P, Soyez F, Chouaid C, Saulnier P, Gagnadoux F. Association of Sleep-Related Hypoxemia With Survival in Patients With Non-Small Cell Lung Cancer: The NEOSAS Groupe Francais de Pneumo-Cancerologie Study Group. Chest. 2026 Mar 9:S0012-3692(26)00279-5. doi: 10.1016/j.chest.2025.12.060. Online ahead of print.
PubMed 41812988
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Sleep-disordered Breathing in Patients With a Newly Diagnosed Non Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT02648087
- Acronym / sponsor ID
- NEOSAS / 2015 -A00395 - 44
- Conditions
- Bronchial Cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,200 participants (estimated)
- Lead sponsor
- University Hospital, AngersOther government
- Study start
- Jan 2016
- Primary completion
- Nov 2018 (estimated)
- Study completion
- Nov 2018 (estimated)
- First posted
- 6 Jan 2016 (estimated)
- 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.
There is a possible implication of sleep apnea syndrome via night-time intermittent hypoxemia in perturbation of quality of life and tumour progression to patients with a bronchial cancer.
The aim of the study is to evaluate this possibility with the help of a night record of sleep and quality of life questionnaires.
Detailed description
There is a possible implication of sleep apnea syndrome via night-time intermittent hypoxemia in perturbation of quality of life and tumour progression to patients with a bronchial cancer.
Enrollment 1200 patients This wide sample is expected to respond to the main and secondary objectives of the study
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| With and without SDB | Other | Device: With and without SDBcomparison of patients with and without sleep-disordered breathing |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- patients with NSCLC undergoing diagnostic
- Performance status 0,1,2
Key exclusion criteria (5 listed)
- >75 years
- OSA known and in the last 12 months treated PS >2
- Patients under a long-term oxygen therapy
- persons deprived of liberty by judicial decision.
- <18 years
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 |
|---|---|---|
| With and without SDBScreening of sleep-disordered breathing (SDB) | Device | With and without SDB |
Primary outcome
Oxygen desaturation index
Time frame: Between day 1 and day 15
RECORDING BY POLYGRAPHY DEVICE between day 1 and day 15 after enrollment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2016.
- Derived from this study: PubMed 41812988Justeau G, Greillier L, Vinas F, Falchero L, Bylicki O, Bernardi M, Martin F, Simon I, Debieuvre D, Locher C, Bizieux-Thaminy A, Levrat V, Fry S, Guguen C, Goutorbe F, Masson P, Soyez F, Chouaid C, Saulnier P, Gagnadoux F. Association of Sleep-Related Hypoxemia With Survival in Patients With Non-Small Cell Lung Cancer: The NEOSAS Groupe Francais de Pneumo-Cancerologie Study Group. Chest. 2026 Mar 9:S0012-3692(26)00279-5. doi: 10.1016/j.chest.2025.12.060. Online ahead of print.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing With and without SDB in people with Bronchial Cancer, run by University Hospital, Angers.
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 2 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 6 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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?
Oxygen desaturation index (time frame: Between day 1 and day 15). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02648087, which also lists 1 linked publication.
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 6 Jan 2016.