Non-Small Cell Lung CancerNCT02695849
A Study of Prevalence of EGFR Mutations in Participants With NSCLC
An observational study of Non-Small Cell Lung Cancer, run by Hoffmann-La Roche at 2 sites in Jordan.
Trial summary
This is a non-interventional, local, multicenter, cross-sectional study to determine the prevalence of epidermal growth factor receptor (EGFR) mutations in participants diagnosed with non-squamous non-small cell lung cancer (NSCLC). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-Small Cell Lung Cancer
- How many people
- 69 participants
- Where
- 2 sitesJordan
- Study dates
- Mar 2012to May 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Participants with non-squamous non-small cell lung cancer (NSCLC)
Who may be able to join
- Informed consent form signature
- Jordanian male and female participants greater than or equal to (>=) 18 years of age
- Histologically confirmed NSCLC
- Not participating in a study that involves an investigational agent within 30 days prior to enrollment
Who cannot join
- Other primary malignancy
- Fine needle aspiration samples
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: An Epidemiology Study of the Prevalence of Epidermal Growth Factor Receptor (EGFR) Mutations in Patients Diagnosed With Non-squamous Non-small Cell Lung Cancer (NSCLC)
This is a non-interventional, local, multicenter, cross-sectional study to determine the prevalence of epidermal growth factor receptor (EGFR) mutations in participants diagnosed with non-squamous non-small cell lung cancer (NSCLC).
- Conditions
- Non-Small Cell Lung Cancer
- Keywords
- Non-small cell lung cancer (NSCLC)
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
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 |
|---|---|---|
| NSCLC Participants | Participants with non-squamous NSCLC will be enrolled in this study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants with EGFR mutations
Measured: Day 1
Secondary outcomes (1)
Percentage of Participants with types of EGFR mutations
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2016 (estimated)
- Study startMar 2012
- Primary completionMay 2015
- Study completionMay 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by Hoffmann-La RocheThe 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
- Cross-sectional
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Hoffmann-La Roche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02695849
- Sponsor's protocol ID
- ML25269
- Status last verified
- Jul 2016
- First submitted
- 25 Feb 2016
- Last updated
- 4 Jul 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Epidemiology Study of the Prevalence of Epidermal Growth Factor Receptor (EGFR) Mutations in Patients Diagnosed With Non-squamous Non-small Cell Lung Cancer (NSCLC)
- ClinicalTrials.gov ID
- NCT02695849
- Acronym / sponsor ID
- ML25269
- Conditions
- Non-Small Cell Lung Cancer
- Keywords
- Non-small cell lung cancer (NSCLC)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- Mar 2012
- Primary completion
- May 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 1 Mar 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.
This is a non-interventional, local, multicenter, cross-sectional study to determine the prevalence of epidermal growth factor receptor (EGFR) mutations in participants diagnosed with non-squamous non-small cell lung cancer (NSCLC).
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| NSCLC Participants | – | –Participants with non-squamous NSCLC will be enrolled in this study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants with non-squamous non-small cell lung cancer (NSCLC)
Key inclusion criteria (4 listed)
- Informed consent form signature
- Jordanian male and female participants greater than or equal to (>=) 18 years of age
- Histologically confirmed NSCLC
- Not participating in a study that involves an investigational agent within 30 days prior to enrollment
Key exclusion criteria (2 listed)
- Other primary malignancy
- Fine needle aspiration samples
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
Percentage of Participants with EGFR mutations
Time frame: Day 1
1 secondary outcome
Percentage of Participants with types of EGFR mutations
Time frame: Day 1
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 4 Jul 2016.
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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.
Clinical Trials study director
Hoffmann-La Roche
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Non-Small Cell Lung Cancer, run by Hoffmann-La Roche at 2 sites in Jordan.
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 2 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 4 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Jordan. 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?
Percentage of Participants with EGFR mutations (time frame: Day 1). 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 4 Jul 2016.