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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 is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01562665
First received: February 22, 2012
Last updated: March 22, 2012
Last verified: March 2012
History of Changes
  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:

MedlinePlus related topics: Cancer Lung Cancer
U.S. FDA Resources

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) ] [ Designated as safety issue: No ]

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) ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: February 2012
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01562665

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

No publications provided

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01562665     History of Changes
Other Study ID Numbers: NIS-OAE-XXX-2011/1
Study First Received: February 22, 2012
Last Updated: March 22, 2012
Health Authority: United Arab Emirates: Drug Control Department - Medicines and Pharmacy Control - Ministry of Health
Kuwait: Joint Committee for the Protection of Human Subjects in Research
Qatar: Hamad Medical Corporation
Bahrain: Ethics Committee

Keywords provided by AstraZeneca:
All patients with NSCLC attending participating hospitals

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
 Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on June 17, 2013