Sleep Apnea and Lung Cancer

Locally Advanced Non Small Cell Lung Cancer Clinical Trial

Official title:

Prognostic Significance of Sleep Apnea in Non Small Cell Lung Cancer

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03741647
• Other study ID #: ZU-IRB #:4791/30-7-2018
• Status: Active, not recruiting
• Start date: November 15, 2018
• Est. completion date: February 2021

Study information

• Verified date: December 2019
• Source: Zagazig University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

cases of locally advanced non small cell lung cancer (diagnosed by PET/CT scan and histopathological confirmation) will be screened for sleep disorders by Epworth sleepiness scale then confirmed by full night polysomnographic study. Blood sample to detect some genetic determinants will be withdrawn

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 50
• Est. completion date: February 2021
• Est. primary completion date: November 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• patients with locally advanced non small cell lung cancer

Exclusion Criteria:

• unable or refuse to perform sleep study

• metastatic cases

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Locally Advanced Non Small Cell Lung Cancer
• Lung Neoplasms

Intervention

Diagnostic Test:
• sleep study and blood sample
full night polysomnographic study and blood sample to detect some genetic issues

Locations

Country	Name	City	State
Egypt	Ahmad Abbas	Zagazig	Asharqia

Sponsors (1)

Lead Sponsor	Collaborator
Zagazig University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	assessment Response to treatment	CT chest/pelvi-abdomen with contrast (evaluation using RECIST criteria)	6 weeks from ending therapy
Primary	confirmed Response to treatment	CT chest/pelvi-abdomen with contrast (evaluation using RECIST criteria)	4 weeks from assessment response
Secondary	Progression Free Survival	CT chest/pelvi-abdomen with contrast (evaluation using RECIST criteria)	3 months from confirmed response to treatment
Secondary	Progression Free Survival	CT chest/pelvi-abdomen with contrast (evaluation using RECIST criteria)	6 months from confirmed response to treatment
Secondary	Progression Free Survival	CT chest/pelvi-abdomen with contrast (evaluation using RECIST criteria)	9 months from confirmed response to treatment
Secondary	Progression Free Survival	CT chest/pelvi-abdomen with contrast (evaluation using RECIST criteria)	12 months from confirmed response to treatment
Secondary	Overall survival	regular patient follow up visit	3 months after enrollment
Secondary	Overall survival	regular patient follow up visit	6 months after enrollment
Secondary	Overall survival	regular patient follow up visit	9 months after enrollment
Secondary	Overall survival	regular patient follow up visit	12 months after enrollment