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Epidemiological Study to Describe Non Small Cell Lung Cancer Clinical Management Patterns in MENA. Lung-EPICLIN/ Gulf (Lung-EPICLIN/G)

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ClinicalTrials.gov Identifier: NCT01562665
Recruitment Status : Completed
First Posted : March 26, 2012
Last Update Posted : May 24, 2016
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

Study Description
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Brief Summary:

The overall aim of the study is:

To provide accurate and reliable information regarding NSCLC clinical management across MENA region in order to detect unmet medical needs of this disease in terms of:

  • Patient and hospital characteristics.
  • Diagnostic and treatment approaches: initial and subsequent.
  • Follow-up patterns in clinical management.
  • Outcomes: symptoms, death, functionality, quality of life.
  • Use of resources and burden on patients and health care systems.

Condition or disease
Non Small Cells Lung Cancer

Detailed Description:
Epidemiological study to describe NSCLC clinical management patterns in MENA
Study Design
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Study Type : Observational
Actual Enrollment : 25 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Epidemiological Study to Describe NSCLC Clinical Management Patterns in MENA
Study Start Date : June 2012
Actual Primary Completion Date : February 2015
Actual Study Completion Date : February 2015

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Groups and Cohorts
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Group/Cohort
All Population
Sample of patients will be invited to complete Quality of Life


Outcome Measures
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Primary Outcome Measures :
  1. Use of health resources by collecting data about hospital description and characteristics, Disease Diagnosis Procedures and Therapy information [ Time Frame: April 2014(26 Months) ]

Secondary Outcome Measures :
  1. Patient-Reported Outcomes (PRO) through self-administered questionnaires and the patients will be asked to complete them at each evaluation visit(25% of the whole sample) [ Time Frame: April 2014(26 Months) ]

Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Oncology Institutes
Criteria

Inclusion Criteria:

  • Confirmed NSCLC diagnosis (e.g. bronchoscope or FNAB), all stages, men and women, attending the responsible department of treating this type of patients for the first time between November 1st, 2011 and August 30th, 2012 For PRO

  • Sub-sample:

    • ability to read and write since they will be asked to participate in the PRO part of the study.
  • Selection will not be based on the disease stage of each patient, in order to avoid a selection bias.

Exclusion Criteria:

  • According to the study design there will not be any exclusion criteria in order to provide a high validity and to obtain the most accurate real daily practice information.
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01562665


Locations
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Bahrain
Research Site
Manama, Bahrain
Qatar
Research Site
Doha, Qatar
United Arab Emirates
Research Site
Alain - AbuAhabi, United Arab Emirates
Sponsors and Collaborators
AstraZeneca
Investigators
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Principal Investigator: Kakil Rasul, CONSULTANT Hamad Medical Corporation, Doha, Qatar
Principal Investigator: Ahmed El Khodary, CONSULTANT Kuwait Cancer Centre, Al Sabah Hospital, Kuwait
Principal Investigator: Norbert Drier, CONSULTANT Zayed Military Hospital, Abu Dhabi, United Arab Emirates
Principal Investigator: Farid Khalifa, CONSULTANT Salmaniya Medical Complex, Bahrain
Principal Investigator: Mohamed Jaloudy, CONSULTANT Tawam Hospital ,Alain,Abu Dhabi, United Arab Emirates
More Information
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Additional Information:

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Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01562665    
Other Study ID Numbers: NIS-OAE-XXX-2011/1
First Posted: March 26, 2012    Key Record Dates
Last Update Posted: May 24, 2016
Last Verified: May 2016
Keywords provided by AstraZeneca:
All patients with NSCLC attending participating hospitals
Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
 Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms