Epidemiological Study to Describe Non-small-cell Lung Carcinoma (NSCLC) Clinical Management Patterns in MENA. Lung-EPICLIN/ KSA (EPICLIN)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.

Verified December 2012 by AstraZeneca.
Recruitment status was: Active, not recruiting

Sponsor:

ClinicalTrials.gov Identifier:

NCT01330862

First Posted: April 7, 2011

Last Update Posted: December 12, 2012

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 study is to provide accurate, reliable information on NSCLC clinical management across MENA (Middle East North Africa) countries in order to detect unmet medical needs of this disease, it is a purely observational study; therefore patients are not assigned to a particular therapeutic strategy beforehand by a protocol. Treatment will be according to current clinical practice.

Condition
NSCLC Patient Characteristics


Study Type:	Observational
Study Design:	Observational Model: Cohort Time Perspective: Prospective
Official Title:	Epidemiological Study to Describe NSCLC Clinical Management Patterns in MENA. Lung-EPICLIN/ KSA

Resource links provided by NLM:

Genetics Home Reference related topics: lung cancer

U.S. FDA Resources

Further study details as provided by AstraZeneca:


Estimated Enrollment:	54
Study Start Date:	April 2011
Estimated Study Completion Date:	March 2013
Estimated Primary Completion Date:	March 2013 (Final data collection date for primary outcome measure)

Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

All NSCLC patients attending the responsible department of treating this type of patients (e.g. Oncology Department) for the first time (regardless of whether the patient is diagnosed with locally, advanced or metastatic disease) at the participating sites from the first of April 2011 to the end of September 2011

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 April 1st 2011 and March 31 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): NCT01330862

Locations


Saudi Arabia
Research Site
Qassim, Central, Saudi Arabia
Research Site
Riyadh, Central, Saudi Arabia
Research Site
Dammam, Eastern, Saudi Arabia
Research Site
Jeddah, Western, Saudi Arabia

Sponsors and Collaborators

AstraZeneca

Investigators


Study Chair:	Dr. Abdul Rahman Jazieh	King Fahad National Guard Hospital
Principal Investigator:	Dr. Ahmed Abdulwarith	King Fahad Specialist Hospital
Principal Investigator:	Dr. Rasha Moastafa	King Fahad Medical City
Principal Investigator:	Dr. Sherif Wafa	Prince Faisal Bin Bander oncology centre
Principal Investigator:	Dr. Maged Mansour	Dr. Erfan & Bagedo Hospital
Principal Investigator:	Dr. Mohamed Rahhal	King Fahad Specialist Hospital

More Information


Responsible Party:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT01330862 History of Changes
Other Study ID Numbers:	NIS-MENA-SA-IRS-2010/01
First Submitted:	March 30, 2011
First Posted:	April 7, 2011
Last Update Posted:	December 12, 2012
Last Verified:	December 2012

Keywords provided by AstraZeneca:


patient outcomes

Additional relevant MeSH terms:


Carcinoma, Non-Small-Cell Lung Carcinoma, Bronchogenic Bronchial Neoplasms Lung Neoplasms Respiratory Tract Neoplasms	Thoracic Neoplasms Neoplasms by Site Neoplasms Lung Diseases Respiratory Tract Diseases

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