- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT02764866
Sleep Apnea in Lung Cancer: A Prospective Study (SAIL)
Prevalence of Sleep Apnea in Lung Cancer
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
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Madrid, Spanien, 28040
- Fundación Jiménez Díaz
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Diagnostisk
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Eksperimentel: 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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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
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Prevalence of sleep disordered breathing in lung cancer
Tidsramme: 12 months
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12 months
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Sekundære resultatmål
Resultatmål |
Tidsramme |
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Survival of lung cancer in patients with sleep disordered breathing
Tidsramme: 36 months
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36 months
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Lung cancer stage in patients with sleep disordered breathing
Tidsramme: 12 months
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12 months
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Lung cancer progression free survival in patients with sleep disordered breathing
Tidsramme: 36 months
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36 months
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Samarbejdspartnere og efterforskere
Efterforskere
- Ledende efterforsker: Luis M Seijo, MD, PhD, Instituto de Investigacion Fundacion Jimenez Diaz
Publikationer og nyttige links
Hjælpsomme links
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- Patologiske processer
- Sygdomme i nervesystemet
- Luftvejssygdomme
- Neoplasmer
- Apnø
- Respirationsforstyrrelser
- Søvnforstyrrelser, iboende
- Dyssomnier
- Søvnvågningsforstyrrelser
- Lungesygdomme
- Neoplasmer efter sted
- Neoplasmer i luftvejene
- Thoracale neoplasmer
- Søvnapnø syndromer
- Lungeneoplasmer
- Respiratorisk aspiration
Andre undersøgelses-id-numre
- InstitutoFJD
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
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