- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT02764866
Sleep Apnea in Lung Cancer: A Prospective Study (SAIL)
Prevalence of Sleep Apnea in Lung Cancer
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
Obstructive sleep apnea hypopnea syndrome (OSAHS) is an important medical condition which causes significant morbidity and mortality. The prevalence of OSAHS in Spain is 4-6% in men and 2-4% in women and rises steadily with age. Snoring and smoking have been independently linked, and smoking may be a risk factor for developing OSAHS. This is particularly true of heavy smokers (> 2 packs/day), those at greatest risk for LC. Associations between OSAHS and some forms of cancer have been described in humans, especially in those experiencing nocturnal hypoxemia, and intermittent hypoxia has been linked to the progression of cancer in animal models. LC is currently the leading cause of cancer deaths in developped nations. A link between OSAHS and LC, therefore, is plausible.
Sleep disordered breathing may be common among patients recently diagnosed of lung cancer and may contribute to tumor progression.
Objectives: a) To perform home sleep testing in patients recently diagnosed with lung cancer in order to determine the prevalence of sleep disordered breathing in this patient population. b) To include biological samples obtained from all participants, including surgically treated patients with stage I / IIp LC through the program in the CIBERES Pulmonary Biobank Platform. Biological samples will be preserved under different storage conditions for subsequent determination of molecular biomarkers. c) To follow-up lung cancer patients with and without sleep disordered breathing in order to determine the potential influence OSAHS might have on their prognosis.
Prospective screening for sleep disordered breathing will be performed by home sleep testing in 100 subjects diagnosed with lung cancer, irrespective of stage at diagnosis, who give their consent. A modified epidemiologic questionnaire for sleep disordered breathing will also be administered. Patients identified as suffering from OSAHS will be referred to sleep clinic. Biologic samples and lung function studies will be obtained in all participating patients.
All patients with lung cancer will undergo follow-up for at least three years or until their demise, and those identified with OSAHS will also be followed in sleep clinic. The prevalence of OSAHS in this patient population will be determined. A link between OSAHS, and especially intermittent nocturnal hypoxemia, and tumor progression will be sought.
Studietyp
Inskrivning (Faktisk)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
-
-
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Madrid, Spanien, 28040
- Fundación Jiménez Díaz
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
Inclusion Criteria:
- All patients with recently diagnosed lung cancer, inlcuding all stages of disease.
Exclusion Criteria:
- Patients unable to comply with home sleep testing.
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Diagnostisk
- Tilldelning: N/A
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
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Experimentell: Sleep testing
Enrolled patients with lung cáncer will undergo home sleep testing during their initial oncologic evaluation, prior to treatment.
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Home sleep testing
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
|---|---|
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Prevalence of sleep disordered breathing in lung cancer
Tidsram: 12 months
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12 months
|
Sekundära resultatmått
Resultatmått |
Tidsram |
|---|---|
|
Survival of lung cancer in patients with sleep disordered breathing
Tidsram: 36 months
|
36 months
|
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Lung cancer stage in patients with sleep disordered breathing
Tidsram: 12 months
|
12 months
|
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Lung cancer progression free survival in patients with sleep disordered breathing
Tidsram: 36 months
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36 months
|
Samarbetspartners och utredare
Utredare
- Huvudutredare: Luis M Seijo, MD, PhD, Instituto de Investigacion Fundacion Jimenez Diaz
Publikationer och användbara länkar
Användbara länkar
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- InstitutoFJD
Plan för individuella deltagardata (IPD)
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