Clinical trial NCT01562665: Epidemiological Study to Describe Non Small Cell Lung Cancer Clinical Management Patterns in MENA. Lung-EPICLIN/ Gulf
Official title: Epidemiological Study to Describe NSCLC Clinical Management Patterns in MENA
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Non Small Cells Lung Cancer
Keywords: All patients with NSCLC attending participating hospitals
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2012-03-26
Enrollment: 25
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Oncology Institutes

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.

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

Eligibility 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.

Primary outcomes:
measure: Use of health resources by collecting data about hospital description and characteristics, Disease Diagnosis Procedures and Therapy information
timeFrame: April 2014(26 Months)
Secondary outcomes:
measure: 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)
timeFrame: April 2014(26 Months)
Other outcomes:
Locations:
city: Manama
country: Bahrain
facility: Research Site
city: Doha
country: Qatar
facility: Research Site
city: Alain - AbuAhabi
country: United Arab Emirates
facility: Research Site
Study officials:
affiliation: Hamad Medical Corporation, Doha, Qatar
name: Kakil Rasul, CONSULTANT
role: PRINCIPAL_INVESTIGATOR
affiliation: Kuwait Cancer Centre, Al Sabah Hospital, Kuwait
name: Ahmed El Khodary, CONSULTANT
role: PRINCIPAL_INVESTIGATOR
affiliation: Zayed Military Hospital, Abu Dhabi, United Arab Emirates
name: Norbert Drier, CONSULTANT
role: PRINCIPAL_INVESTIGATOR
affiliation: Salmaniya Medical Complex, Bahrain
name: Farid Khalifa, CONSULTANT
role: PRINCIPAL_INVESTIGATOR
affiliation: Tawam Hospital ,Alain,Abu Dhabi, United Arab Emirates
name: Mohamed Jaloudy, CONSULTANT
role: PRINCIPAL_INVESTIGATOR
References: