Lung CancerNCT02845089
Treatment Patterns, Outcomes and Resource Use Study for Advanced Stage Non-Small Cell Lung Cancer (Squamous and Non-squamous) in the Kingdom of Saudi Arabia and United Arab Emirates
An observational study of Lung Cancer, run by Bristol-Myers Squibb.
Trial summary
A retrospective observational longitudinal medical chart review study of randomly sampled patients diagnosed with advanced/metastatic NSCLC. The minimum observational period for each patient will be 12 months. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer
- How many people
- 382 participants
- Where
- No sites listed yet
- Study dates
- 29 Feb 2016to 15 Aug 2017
- 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: A random sample of patients diagnosed with advanced/metastatic NSCLC from select oncology centers in UAE and KSA
Who may be able to join
- Adults 18 years and older at the time of advanced/metastatic NSCLC diagnosis, and currently alive or deceased
- Histologically confirmed diagnosis of advanced/metastatic NSCLC (squamous, non-squamous or NOS) stages IIIB/IV. First diagnosis of advanced/metastatic NSCLC between 01-Jan-2010 and 31-Mar-2014 (currently alive or deceased) with a minimum 12 months of potential observation period available in medical records
- Medical history and treatment data must be available (or obtainable by SI) for chart abstraction from the date of advanced/metastatic diagnosis through most recent patient follow-up/contact. This also includes documentation of treatment by other physicians and inpatient hospital treatments within KSA or the Health Authority of Abu Dhabi (HAAD) system
- Patients must have at least all data on age, gender, date of advanced NSCLC diagnosis, Line of Treatment (LOT) information (agent types and dosage), and date of last follow-up
Who cannot join
- Patient had enrolled in a cancer treatment-related clinical study at any time after the diagnosis of advanced/metastatic NSCLC
About this study
A retrospective observational longitudinal medical chart review study of randomly sampled patients diagnosed with advanced/metastatic NSCLC. The minimum observational period for each patient will be 12 months.
- Conditions
- Lung Cancer
- Medical subject headings
- Lung Neoplasms
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 |
|---|---|---|
| Advanced/Metastatic NSCLC patients from UAE and KSA | A random sample of patients diagnosed with advanced/metastatic non-small cell lung cancer (NSCLC) from select oncology centers in Kingdom of Saudi Arabia (KSA) and United Arab Emirates (UAE) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Demographics at diagnosis with advanced/metastatic NSCLC
Measured: at baseline
Systemic treatments prescribed for NSCLC patients from treatment initiation through discontinuation
Measured: approximately 12 months
Duration of systemic treatments
Measured: approximately 12 months
Distribution of reasons for discontinuing treatment
Measured: approximately 12 months
Secondary outcomes (4)
healthcare resource utilization in patients with advanced/metastatic NSCLC
NSCLC-related health care resources associated with the provision of systemic treatments and managing side effects of treatments: hospital admissions including emergency room visits
Measured: approximately 12 months
Progression-Free Survival (PFS)
Measured: approximately 12 months
Overall Survival (OS)
Measured: approximately 12 months
Adverse Events (AEs)
Measured: approximately 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2016 (estimated)
- Study start29 Feb 2016
- Primary completion31 May 2016
- Study completion15 Aug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- More trials run by Bristol-Myers SquibbThe 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
- Retrospective
- Enrolment
- 382 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02845089
- Sponsor's protocol ID
- CA209-454
- Status last verified
- Mar 2018
- First submitted
- 8 Jul 2016
- Last updated
- 22 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment Patterns, Outcomes and Resource Use Study for Advanced Stage Non-Small Cell Lung Cancer (Squamous and Non-squamous) in the Kingdom of Saudi Arabia and United Arab Emirates
- ClinicalTrials.gov ID
- NCT02845089
- Acronym / sponsor ID
- CA209-454
- Conditions
- Lung Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 382 participants (estimated)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- 29 Feb 2016 (actual)
- Primary completion
- 31 May 2016 (actual)
- Study completion
- 15 Aug 2017 (actual)
- First posted
- 27 Jul 2016 (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.
A retrospective observational longitudinal medical chart review study of randomly sampled patients diagnosed with advanced/metastatic NSCLC. The minimum observational period for each patient will be 12 months.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Advanced/Metastatic NSCLC patients from UAE and KSA | – | –A random sample of patients diagnosed with advanced/metastatic non-small cell lung cancer (NSCLC) from select oncology centers in Kingdom of Saudi Arabia (KSA) and United Arab Emirates (UAE) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- A random sample of patients diagnosed with advanced/metastatic NSCLC from select oncology centers in UAE and KSA
Key inclusion criteria (4 listed)
- Adults 18 years and older at the time of advanced/metastatic NSCLC diagnosis, and currently alive or deceased
- Histologically confirmed diagnosis of advanced/metastatic NSCLC (squamous, non-squamous or NOS) stages IIIB/IV. First diagnosis of advanced/metastatic NSCLC between 01-Jan-2010 and 31-Mar-2014 (currently alive or deceased) with a minimum 12 months of potential observation period available in medical records
- Medical history and treatment data must be available (or obtainable by SI) for chart abstraction from the date of advanced/metastatic diagnosis through most recent patient follow-up/contact. This also includes documentation of treatment by other physicians and inpatient hospital treatments within KSA or the Health Authority of Abu Dhabi (HAAD) system
- Patients must have at least all data on age, gender, date of advanced NSCLC diagnosis, Line of Treatment (LOT) information (agent types and dosage), and date of last follow-up
Key exclusion criteria (1 listed)
- Patient had enrolled in a cancer treatment-related clinical study at any time after the diagnosis of advanced/metastatic NSCLC
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
Patient Demographics at diagnosis with advanced/metastatic NSCLC
Time frame: at baseline
Systemic treatments prescribed for NSCLC patients from treatment initiation through discontinuation
Time frame: approximately 12 months
Duration of systemic treatments
Time frame: approximately 12 months
Distribution of reasons for discontinuing treatment
Time frame: approximately 12 months
4 secondary outcomes
healthcare resource utilization in patients with advanced/metastatic NSCLC
Time frame: approximately 12 months
Progression-Free Survival (PFS)
Time frame: approximately 12 months
Overall Survival (OS)
Time frame: approximately 12 months
Adverse Events (AEs)
Time frame: approximately 12 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 22 Mar 2018.
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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.
Bristol-Myers Squibb study director
Bristol-Myers Squibb
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Cancer, run by Bristol-Myers Squibb.
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 22 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
Patient Demographics at diagnosis with advanced/metastatic NSCLC (time frame: at baseline). The study lists 4 primary outcomes in all. 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 22 Mar 2018; AzTrials last refreshed its copy on 29 Oct 2026.