Sleep Apnea and Lung Cancer

December 25, 2019 updated by: Ahmad Abbas, Zagazig University

Prognostic Significance of Sleep Apnea in Non Small Cell Lung Cancer

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 Blood sample to detect some genetic determinants will be withdrawn

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
    • Asharqia
      • Zagazig, Asharqia, Egypt, 44519
        • Ahmad Abbas

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

- patients with locally advanced non small cell lung cancer diagnosed, managed and followed up in clinical oncology department, zagazig university hospitals

Description

Inclusion Criteria:

  • patients with locally advanced non small cell lung cancer

Exclusion Criteria:

  • unable or refuse to perform sleep study
  • metastatic cases

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
assessment Response to treatment
Time Frame: 6 weeks from ending therapy
CT chest/pelvi-abdomen with contrast (evaluation using RECIST criteria)
6 weeks from ending therapy
confirmed Response to treatment
Time Frame: 4 weeks from assessment response
CT chest/pelvi-abdomen with contrast (evaluation using RECIST criteria)
4 weeks from assessment response

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression Free Survival
Time Frame: 3 months from confirmed response to treatment
CT chest/pelvi-abdomen with contrast (evaluation using RECIST criteria)
3 months from confirmed response to treatment
Progression Free Survival
Time Frame: 6 months from confirmed response to treatment
CT chest/pelvi-abdomen with contrast (evaluation using RECIST criteria)
6 months from confirmed response to treatment
Progression Free Survival
Time Frame: 9 months from confirmed response to treatment
CT chest/pelvi-abdomen with contrast (evaluation using RECIST criteria)
9 months from confirmed response to treatment
Progression Free Survival
Time Frame: 12 months from confirmed response to treatment
CT chest/pelvi-abdomen with contrast (evaluation using RECIST criteria)
12 months from confirmed response to treatment
Overall survival
Time Frame: 3 months after enrollment
regular patient follow up visit
3 months after enrollment
Overall survival
Time Frame: 6 months after enrollment
regular patient follow up visit
6 months after enrollment
Overall survival
Time Frame: 9 months after enrollment
regular patient follow up visit
9 months after enrollment
Overall survival
Time Frame: 12 months after enrollment
regular patient follow up visit
12 months after enrollment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zagazig University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 15, 2018

Primary Completion (Anticipated)

November 1, 2020

Study Completion (Anticipated)

February 1, 2021

Study Registration Dates

First Submitted

September 21, 2018

First Submitted That Met QC Criteria

November 13, 2018

First Posted (Actual)

November 15, 2018

Study Record Updates

Last Update Posted (Actual)

December 30, 2019

Last Update Submitted That Met QC Criteria

December 25, 2019

Last Verified

December 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ZU-IRB #:4791/30-7-2018

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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