NSCLC Patient CharacteristicsEPICLINNCT01330862
Epidemiological Study to Describe Non-small-cell Lung Carcinoma (NSCLC) Clinical Management Patterns in MENA. Lung-EPICLIN/ KSA
An observational study of NSCLC Patient Characteristics, run by AstraZeneca at 4 sites in Saudi Arabia.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- NSCLC Patient Characteristics
- How many people
- 54 participants
- Where
- 4 sitesSaudi Arabia
- Study dates
- Apr 2011to Mar 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
4 sites in 1 country.
Saudi Arabia4 sites
Research Site
Dammam, Eastern Province
Research Site
Jeddah, Western
Research Site
Qassim, Central
Research Site
Riyadh, Central
About this study
Official title: 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.
- Conditions
- NSCLC Patient Characteristics
- Keywords
- patient outcomes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2011 (estimated)
- Study startApr 2011
- Primary completionMar 2013 (estimated)
- Study completionMar 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NSCLC Patient CharacteristicsStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 54 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dr. Abdul Rahman Jazieh, Study chair, King Fahad National Guard HospitalDr. Ahmed Abdulwarith, Principal investigator, King Fahad Specialist HospitalDr. Rasha Moastafa, Principal investigator, King Fahad Medical CityDr. Sherif Wafa, Principal investigator, Prince Faisal Bin Bander oncology centreDr. Maged Mansour, Principal investigator, Dr. Erfan & Bagedo HospitalDr. Mohamed Rahhal, Principal investigator, King Fahad Specialist Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01330862
- Sponsor's protocol ID
- NIS-MENA-SA-IRS-2010/01
- Acronym
- EPICLIN
- Status last verified
- Dec 2012
- First submitted
- 30 Mar 2011
- Last updated
- 12 Dec 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Epidemiological Study to Describe NSCLC Clinical Management Patterns in MENA. Lung-EPICLIN/ KSA
- ClinicalTrials.gov ID
- NCT01330862
- Acronym / sponsor ID
- EPICLIN / NIS-MENA-SA-IRS-2010/01
- Conditions
- NSCLC Patient Characteristics
- Keywords
- patient outcomes
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Apr 2011
- Primary completion
- Mar 2013 (estimated)
- Study completion
- Mar 2013 (estimated)
- First posted
- 7 Apr 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dr. Abdul Rahman Jazieh study chair
King Fahad National Guard Hospital
Dr. Ahmed Abdulwarith principal investigator
King Fahad Specialist Hospital
Dr. Rasha Moastafa principal investigator
King Fahad Medical City
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of NSCLC Patient Characteristics, run by AstraZeneca at 4 sites in Saudi Arabia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Dec 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Saudi Arabia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Dec 2012.