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

Non Small Cells Lung Cancer Clinical Trial

— Lung-EPICLIN/G  

Official title:

Epidemiological Study to Describe NSCLC Clinical Management Patterns in MENA

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01562665
• Other study ID #: NIS-OAE-XXX-2011/1
• Status: Completed
• Phase: N/A
• First received: February 22, 2012
• Last updated: May 23, 2016
• Start date: June 2012
• Est. completion date: February 2015

Study information

• Verified date: May 2016
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Arab Emirates: Drug Control Department - Medicines and Pharmacy Control - Ministry of HealthKuwait: Joint Committee for the Protection of Human Subjects in ResearchQatar: Hamad Medical CorporationBahrain: Ethics Committee
• Study type: Observational

Clinical Trial 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.

Description:

Epidemiological study to describe NSCLC clinical management patterns in MENA

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: February 2015
• Est. primary completion date: February 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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 Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Non Small Cells Lung Cancer

Locations

Country	Name	City	State
Bahrain	Research Site	Manama
Qatar	Research Site	Doha
United Arab Emirates	Research Site	Alain - AbuAhabi

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Countries where clinical trial is conducted

Bahrain,  Qatar,  United Arab Emirates, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Use of health resources by collecting data about hospital description and characteristics, Disease Diagnosis Procedures and Therapy information		April 2014(26 Months)	No
Secondary	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)		April 2014(26 Months)	No

External Links

•   EpiclinStudy_Synopsis