NCT03741647

Brief 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 Blood sample to detect some genetic determinants will be withdrawn

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Nov 2018

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 21, 2018

Completed
2 months until next milestone

First Posted

Study publicly available on registry

November 15, 2018

Completed
Same day until next milestone

Study Start

First participant enrolled

November 15, 2018

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2020

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2021

Completed
Last Updated

December 30, 2019

Status Verified

December 1, 2019

Enrollment Period

2 years

First QC Date

September 21, 2018

Last Update Submit

December 25, 2019

Conditions

Locally Advanced Non Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (2)

  • assessment Response to treatment

    CT chest/pelvi-abdomen with contrast (evaluation using RECIST criteria)

    6 weeks from ending therapy

  • confirmed Response to treatment

    CT chest/pelvi-abdomen with contrast (evaluation using RECIST criteria)

    4 weeks from assessment response

Secondary Outcomes (8)

  • Progression Free Survival

    3 months from confirmed response to treatment

  • Progression Free Survival

    6 months from confirmed response to treatment

  • Progression Free Survival

    9 months from confirmed response to treatment

  • Progression Free Survival

    12 months from confirmed response to treatment

  • Overall survival

    3 months after enrollment

  • +3 more secondary outcomes

Interventions

sleep study and blood sampleDIAGNOSTIC_TEST

full night polysomnographic study and blood sample to detect some genetic issues

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • patients with locally advanced non small cell lung cancer

You may not qualify if:

  • unable or refuse to perform sleep study
  • metastatic cases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ahmad Abbas

Zagazig, Asharqia, 44519, Egypt

Location

MeSH Terms

Interventions

PolysomnographyBlood Specimen Collection

Intervention Hierarchy (Ancestors)

Monitoring, PhysiologicDiagnostic Techniques and ProceduresDiagnosisSpecimen HandlingClinical Laboratory TechniquesPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator &lecturer of chest disases zagazig university

Study Record Dates

First Submitted

September 21, 2018

First Posted

November 15, 2018

Study Start

November 15, 2018

Primary Completion

November 1, 2020

Study Completion

February 1, 2021

Last Updated

December 30, 2019

Record last verified: 2019-12

Locations

EG(1)