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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01330862
First received: March 30, 2011
Last updated: December 11, 2012
Last verified: December 2012
  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

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01330862     History of Changes
Other Study ID Numbers: NIS-MENA-SA-IRS-2010/01
Study First Received: March 30, 2011
Last Updated: December 11, 2012
Health Authority: Saudi Arabia: Ethics Committee

Keywords provided by AstraZeneca:
patient outcomes

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Bronchial Neoplasms
Carcinoma, Bronchogenic
Lung Diseases
Lung Neoplasms
Neoplasms
Neoplasms by Site
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms

ClinicalTrials.gov processed this record on October 23, 2014