Locally Advanced Non Small Cell Lung CancerNCT03741647
Sleep Apnea and Lung Cancer
An observational study of Locally Advanced Non Small Cell Lung Cancer, run by Zagazig University at 1 site in Egypt.
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 Blood sample to detect some genetic determinants will be withdrawn Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Locally Advanced Non Small Cell Lung Cancer
- What is being tested?
- sleep study and blood sample
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Nov 2018to Feb 2021
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: - patients with locally advanced non small cell lung cancer diagnosed, managed and followed up in clinical oncology department, zagazig university hospitals
Who may be able to join
- patients with locally advanced non small cell lung cancer
Who cannot join
- unable or refuse to perform sleep study
- metastatic cases
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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 Blood sample to detect some genetic determinants will be withdrawn
- Being tested
- sleep study and blood sample
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sleep study and blood sampleDiagnostic test
full night polysomnographic study and blood sample to detect some genetic issues
What is being measured
The primary outcome is the main question the study is designed to answer.
assessment Response to treatment
CT chest/pelvi-abdomen with contrast (evaluation using RECIST criteria)
Measured: 6 weeks from ending therapy
confirmed Response to treatment
CT chest/pelvi-abdomen with contrast (evaluation using RECIST criteria)
Measured: 4 weeks from assessment response
Secondary outcomes (8)
Progression Free Survival
CT chest/pelvi-abdomen with contrast (evaluation using RECIST criteria)
Measured: 3 months from confirmed response to treatment
Progression Free Survival
CT chest/pelvi-abdomen with contrast (evaluation using RECIST criteria)
Measured: 6 months from confirmed response to treatment
Progression Free Survival
CT chest/pelvi-abdomen with contrast (evaluation using RECIST criteria)
Measured: 9 months from confirmed response to treatment
Progression Free Survival
CT chest/pelvi-abdomen with contrast (evaluation using RECIST criteria)
Measured: 12 months from confirmed response to treatment
Overall survival
regular patient follow up visit
Measured: 3 months after enrollment
Overall survival
regular patient follow up visit
Measured: 6 months after enrollment
Overall survival
regular patient follow up visit
Measured: 9 months after enrollment
Overall survival
regular patient follow up visit
Measured: 12 months after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2018
- Study start15 Nov 2018
- Primary completionNov 2020 (estimated)
- Study completionFeb 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Locally Advanced Non Small Cell Lung CancerStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zagazig University
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Ahmad Abbas, Zagazig University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03741647
- Sponsor's protocol ID
- ZU-IRB #:4791/30-7-2018
- Status last verified
- Dec 2019
- First submitted
- 21 Sep 2018
- Last updated
- 30 Dec 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prognostic Significance of Sleep Apnea in Non Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT03741647
- Acronym / sponsor ID
- ZU-IRB #:4791/30-7-2018
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Zagazig UniversityOther government
- Study start
- 15 Nov 2018 (actual)
- Primary completion
- Nov 2020 (estimated)
- Study completion
- Feb 2021 (estimated)
- First posted
- 15 Nov 2018 (actual)
- 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.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- - patients with locally advanced non small cell lung cancer diagnosed, managed and followed up in clinical oncology department, zagazig university hospitals
Key inclusion criteria (1 listed)
- patients with locally advanced non small cell lung cancer
Key exclusion criteria (2 listed)
- unable or refuse to perform sleep study
- metastatic cases
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 |
|---|---|---|
| sleep study and blood samplefull night polysomnographic study and blood sample to detect some genetic issues | Diagnostic test | – |
Primary outcome
assessment Response to treatment
Time frame: 6 weeks from ending therapy
CT chest/pelvi-abdomen with contrast (evaluation using RECIST criteria)
confirmed Response to treatment
Time frame: 4 weeks from assessment response
CT chest/pelvi-abdomen with contrast (evaluation using RECIST criteria)
8 secondary outcomes
Progression Free Survival
Time frame: 3 months from confirmed response to treatment
Progression Free Survival
Time frame: 6 months from confirmed response to treatment
Progression Free Survival
Time frame: 9 months from confirmed response to treatment
Progression Free Survival
Time frame: 12 months from confirmed response to treatment
Overall survival
Time frame: 3 months after enrollment
Overall survival
Time frame: 6 months after enrollment
Overall survival
Time frame: 9 months after enrollment
Overall survival
Time frame: 12 months after enrollment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Dec 2019.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Locally Advanced Non Small Cell Lung Cancer, run by Zagazig University at 1 site in Egypt.
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 1 inclusion and 2 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 30 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
assessment Response to treatment (time frame: 6 weeks from ending therapy). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Dec 2019.