- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01330862
Epidemiological Study to Describe Non-small-cell Lung Carcinoma (NSCLC) Clinical Management Patterns in MENA. Lung-EPICLIN/ KSA (EPICLIN)
December 11, 2012 updated by: AstraZeneca
Epidemiological Study to Describe NSCLC Clinical Management Patterns in MENA. Lung-EPICLIN/ KSA
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.
Study Overview
Status
Unknown
Conditions
Study Type
Observational
Enrollment (Anticipated)
54
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
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Central
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Qassim, Central, Saudi Arabia
- Research Site
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Riyadh, Central, Saudi Arabia
- Research Site
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Eastern
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Dammam, Eastern, Saudi Arabia
- Research Site
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Western
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Jeddah, Western, Saudi Arabia
- Research Site
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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
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
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
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 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.
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
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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
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
April 1, 2011
Primary Completion (Anticipated)
March 1, 2013
Study Completion (Anticipated)
March 1, 2013
Study Registration Dates
First Submitted
March 30, 2011
First Submitted That Met QC Criteria
April 6, 2011
First Posted (Estimate)
April 7, 2011
Study Record Updates
Last Update Posted (Estimate)
December 12, 2012
Last Update Submitted That Met QC Criteria
December 11, 2012
Last Verified
December 1, 2012
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- NIS-MENA-SA-IRS-2010/01
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.