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

May 23, 2016 updated by: AstraZeneca

Epidemiological Study to Describe NSCLC Clinical Management Patterns in MENA

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.

Study Overview

Status

Completed

Conditions

Detailed Description

Epidemiological study to describe NSCLC clinical management patterns in MENA

Study Type

Observational

Enrollment (Actual)

25

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Oncology Institutes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
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)
April 2014(26 Months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2012

Primary Completion (Actual)

February 1, 2015

Study Completion (Actual)

February 1, 2015

Study Registration Dates

First Submitted

February 22, 2012

First Submitted That Met QC Criteria

March 22, 2012

First Posted (Estimate)

March 26, 2012

Study Record Updates

Last Update Posted (Estimate)

May 24, 2016

Last Update Submitted That Met QC Criteria

May 23, 2016

Last Verified

May 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NIS-OAE-XXX-2011/1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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