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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT01330862
Other study ID # NIS-MENA-SA-IRS-2010/01
Secondary ID
Status Active, not recruiting
Phase N/A
First received March 30, 2011
Last updated December 11, 2012
Start date April 2011
Est. completion date March 2013

Study information

Verified date December 2012
Source AstraZeneca
Contact n/a
Is FDA regulated No
Health authority Saudi Arabia: Ethics Committee
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 54
Est. completion date March 2013
Est. primary completion date March 2013
Accepts healthy volunteers No
Gender Both
Age group 18 Years 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 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 Design

Observational Model: Cohort, Time Perspective: Prospective


Locations

Country Name City State
Saudi Arabia Research Site Dammam Eastern
Saudi Arabia Research Site Jeddah Western
Saudi Arabia Research Site Qassim Central
Saudi Arabia Research Site Riyadh Central

Sponsors (1)

Lead Sponsor Collaborator
AstraZeneca

Country where clinical trial is conducted

Saudi Arabia,