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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01562665
First Posted: March 26, 2012
Last Update Posted: May 24, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
AstraZeneca
  Purpose

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
Non Small Cells Lung Cancer

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Epidemiological Study to Describe NSCLC Clinical Management Patterns in MENA

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • 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:
  • 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) ]

Enrollment: 25
Study Start Date: June 2012
Study Completion Date: February 2015
Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
All Population
Sample of patients will be invited to complete Quality of Life

Detailed Description:
Epidemiological study to describe NSCLC clinical management patterns in MENA
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
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
Information from the National Library of Medicine

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
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
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

Additional Information:
Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01562665     History of Changes
Other Study ID Numbers: NIS-OAE-XXX-2011/1
First Submitted: February 22, 2012
First Posted: March 26, 2012
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:
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