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

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ClinicalTrials.gov Identifier: NCT01330862
Recruitment Status : Unknown
Verified December 2012 by AstraZeneca.
Recruitment status was:  Active, not recruiting
First Posted : April 7, 2011
Last Update Posted : December 12, 2012
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

Study Description
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Brief Summary:
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 or disease
NSCLC Patient Characteristics

Study Design
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Study Type : Observational
Estimated Enrollment : 54 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Epidemiological Study to Describe NSCLC Clinical Management Patterns in MENA. Lung-EPICLIN/ KSA
Study Start Date : April 2011
Estimated Primary Completion Date : March 2013
Estimated Study Completion Date : March 2013

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U.S. FDA Resources

Groups and Cohorts
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Outcome Measures
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Eligibility Criteria
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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
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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
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01330862     History of Changes
Other Study ID Numbers: NIS-MENA-SA-IRS-2010/01
First Posted: April 7, 2011    Key Record Dates
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