Non Small Cells Lung CancerLung-EPICLIN/GNCT01562665
Epidemiological Study to Describe Non Small Cell Lung Cancer Clinical Management Patterns in MENA. Lung-EPICLIN/ Gulf
An observational study of Non Small Cells Lung Cancer, run by AstraZeneca at 3 sites in 3 countries.
Trial summary
The overall aim of the study is: To provide accurate and reliable information regarding NSCLC clinical management across MENA region in order to detect unmet medical needs of this disease in terms of: Patient and hospital characteristics. Diagnostic and treatment approaches: initial and subsequent. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Non Small Cells Lung Cancer
- How many people
- 25 participants
- Where
- 3 sitesin 3 countries
- Study dates
- Jun 2012to Feb 2015
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Oncology Institutes
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 November 1st, 2011 and August 30th, 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
3 sites in 3 countries.
3 sites in 3 countries
About this study
Official title: Epidemiological Study to Describe NSCLC Clinical Management Patterns in MENA
The overall aim of the study is:
To provide accurate and reliable information regarding NSCLC clinical management across MENA region in order to detect unmet medical needs of this disease in terms of:
- Patient and hospital characteristics.
- Diagnostic and treatment approaches: initial and subsequent.
- Follow-up patterns in clinical management.
- Outcomes: symptoms, death, functionality, quality of life.
- Use of resources and burden on patients and health care systems.
Read the detailed description
Epidemiological study to describe NSCLC clinical management patterns in MENA
- Conditions
- Non Small Cells Lung Cancer
- Keywords
- All patients with NSCLC attending participating hospitals
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| All Population | Not described | |
| Sample of patients will be invited to complete Quality of Life | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Use of health resources by collecting data about hospital description and characteristics, Disease Diagnosis Procedures and Therapy information
Measured: April 2014(26 Months)
Secondary outcomes (1)
Patient-Reported Outcomes (PRO) through self-administered questionnaires and the patients will be asked to complete them at each evaluation visit(25% of the whole sample)
Measured: April 2014(26 Months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2012 (estimated)
- Study startJun 2012
- Primary completionFeb 2015
- Study completionFeb 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non Small Cells Lung CancerStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kakil Rasul, CONSULTANT, Principal investigator, Hamad Medical Corporation, Doha, QatarAhmed El Khodary, CONSULTANT, Principal investigator, Kuwait Cancer Centre, Al Sabah Hospital, KuwaitNorbert Drier, CONSULTANT, Principal investigator, Zayed Military Hospital, Abu Dhabi, United Arab EmiratesFarid Khalifa, CONSULTANT, Principal investigator, Salmaniya Medical Complex, BahrainMohamed Jaloudy, CONSULTANT, Principal investigator, Tawam Hospital ,Alain,Abu Dhabi, United Arab Emirates
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01562665
- Sponsor's protocol ID
- NIS-OAE-XXX-2011/1
- Acronym
- Lung-EPICLIN/G
- Status last verified
- May 2016
- First submitted
- 22 Feb 2012
- Last updated
- 24 May 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2016. 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
- ClinicalTrials.gov ID
- NCT01562665
- Acronym / sponsor ID
- Lung-EPICLIN/G / NIS-OAE-XXX-2011/1
- Conditions
- Non Small Cells Lung Cancer
- Keywords
- All patients with NSCLC attending participating hospitals
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Jun 2012
- Primary completion
- Feb 2015 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 26 Mar 2012 (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 overall aim of the study is:
To provide accurate and reliable information regarding NSCLC clinical management across MENA region in order to detect unmet medical needs of this disease in terms of:
- Patient and hospital characteristics.
- Diagnostic and treatment approaches: initial and subsequent.
- Follow-up patterns in clinical management.
- Outcomes: symptoms, death, functionality, quality of life.
- Use of resources and burden on patients and health care systems.
Detailed description
Epidemiological study to describe NSCLC clinical management patterns in MENA
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| All Population | – | – |
| Sample of patients will be invited to complete Quality of Life | – | – |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Oncology Institutes
Key inclusion criteria (4 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 November 1st, 2011 and August 30th, 2012 For PRO
- Sub-sample:
- 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
Use of health resources by collecting data about hospital description and characteristics, Disease Diagnosis Procedures and Therapy information
Time frame: April 2014(26 Months)
1 secondary outcome
Patient-Reported Outcomes (PRO) through self-administered questionnaires and the patients will be asked to complete them at each evaluation visit(25% of the whole sample)
Time frame: April 2014(26 Months)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2016.
- EpiclinStudy\_SynopsisLink provided by the sponsor.
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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.
Kakil Rasul, CONSULTANT principal investigator
Hamad Medical Corporation, Doha, Qatar
Ahmed El Khodary, CONSULTANT principal investigator
Kuwait Cancer Centre, Al Sabah Hospital, Kuwait
Norbert Drier, CONSULTANT principal investigator
Zayed Military Hospital, Abu Dhabi, United Arab Emirates
3 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Non Small Cells Lung Cancer, run by AstraZeneca at 3 sites in 3 countries.
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 4 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: finished, as of the sponsor's last update on 24 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Bahrain, Qatar, United Arab Emirates. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
What does the primary outcome measure?
Use of health resources by collecting data about hospital description and characteristics, Disease Diagnosis Procedures and Therapy information (time frame: April 2014(26 Months)). It is what the study was designed to measure, not a finding.
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 24 May 2016.