Non Small Cell Lung CancerSpanish REASONNCT01081496
Epidemiological Study to Evaluate the Prevalence of Epidermal Growth Factor Receptor (EGFR) Mutation Status in Patients With Newly Diagnosed Locally Advanced or Metastatic Non Small Cell Lung Cancer (NSCLC)
An observational study of Non Small Cell Lung Cancer, run by AstraZeneca at 24 sites in Spain.
Trial summary
To estimate the prevalence of EGFR mutation in a representative sample of patients with newly diagnosed stage IIIB/IV NSCLC in Spain (predominantly Caucasian ethnicity). 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
- 1,000 participants
- Where
- 24 sitesSpain
- Study dates
- Mar 2010to Feb 2011
- 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: To be recruited by Oncologist
Who may be able to join
- Signed written informed consent
- Histologically confirmed locally advanced or metastatic NSCLC (stage IIIB/IV)
Who cannot join
- Mixed histology of small cell and non-small cell lung cancer
Trial locations and contacts
24 sites in 1 country.
24 sites in 1 country
Spain24 sites
Research Site
Albacete, Albacete
Research Site
Alicante, Alicante
Research Site
Barcelona, Barcelona
Research Site
Cáceres, Caceres
Research Site
Córdoba, Cordoba
Research Site
Elche, Alicante
Research Site
Girona, Girona
Research Site
Granada, Granada
Research Site
Jaén, Jaen
Research Site
Lugo, Lugo
Research Site
Madrid, Madrid
Research Site
Málaga, Malaga
Research Site
Murcia, Murcia
Research Site
Oviedo, Principality of Asturias
Research Site
Pamplona, Navarre
Research Site
Pontevedra, Pontevedra
Research Site
Reus, Tarragona
Research Site
Salamanca, Salamanca
Research Site
Santander, Cantabria
Research Site
Santiago de Compostela, A Coruna
Research Site
Seville, Sevilla
Research Site
Valencia, Valencia
Research Site
Vigo, Pontevedra
Research Site
Zaragoza, Zaragoza
About this study
Official title: Epidemiological Study to Evaluate the Prevalence of EGFR Mutation Status in Patients With Newly Diagnosed Locally Advanced or Metastatic NSCLC (Stage IIIB/IV Non-small Cell Lung Cancer)
To estimate the prevalence of EGFR mutation in a representative sample of patients with newly diagnosed stage IIIB/IV NSCLC in Spain (predominantly Caucasian ethnicity).
- Conditions
- Non Small Cell Lung Cancer
- Keywords
- EGFR mutation, Non-small cell lung carcinoma, Spain, Evaluate the prevalence of EGFR mutation status in patients with newly diagnosed locally advanced or metastatic NSCLC
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What is being measured
The primary outcome is the main question the study is designed to answer.
To estimate the prevalence of EGFR mutation in a representative sample of patients with newly diagnosed stage IIIB/IV NSCLC in Spain (predominantly Caucasian ethnicity).
Secondary outcomes (3)
Correlate EGFR mutation status with clinico-pathological characteristics. The study will aim to determine the prevalence of EGFR M+ lung cancers in patients with clinico-pathological characteristics not commonly associated with EGFR mutation positivity
To describe different EGFR mutation methods used in Spain and testing turn around time associated
To determine the % of confirmed stage IIIB/IV NSCLC patients who cannot be tested for EGFR mutation and the reasons for not testing (% of EGFR Mnt)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2010 (estimated)
- Study startMar 2010
- Primary completionAug 2010
- Study completionFeb 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Non Small Cell 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Carmen Gonzalez Arenas, Study director, Medical Department. Mediclin-AstraZeneca. Spain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01081496
- Sponsor's protocol ID
- NIS-OES-DUM-2009/1
- Acronym
- Spanish REASON
- Status last verified
- Mar 2011
- First submitted
- 1 Mar 2010
- Last updated
- 16 Mar 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Esteban E, Majem M, Martinez Aguillo M, Martinez Banaclocha N, Domine M, Gomez Aldaravi L, Juan O, Cajal R, Gonzalez Arenas MC, Provencio M. Prevalence of EGFR mutations in newly diagnosed locally advanced or metastatic non-small cell lung cancer Spanish patients and its association with histological subtypes and clinical features: The Spanish REASON study. Cancer Epidemiol. 2015 Jun;39(3):291-7. doi: 10.1016/j.canep.2015.02.003. Epub 2015 Mar 9.
PubMed 25766256
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Epidemiological Study to Evaluate the Prevalence of EGFR Mutation Status in Patients With Newly Diagnosed Locally Advanced or Metastatic NSCLC (Stage IIIB/IV Non-small Cell Lung Cancer)
- ClinicalTrials.gov ID
- NCT01081496
- Acronym / sponsor ID
- Spanish REASON / NIS-OES-DUM-2009/1
- Conditions
- Non Small Cell Lung Cancer
- Keywords
- EGFR mutation, Non-small cell lung carcinoma, Spain, Evaluate the prevalence of EGFR mutation status in patients with newly diagnosed locally advanced or metastatic NSCLC
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Mar 2010
- Primary completion
- Aug 2010 (actual)
- Study completion
- Feb 2011 (actual)
- First posted
- 5 Mar 2010 (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.
To estimate the prevalence of EGFR mutation in a representative sample of patients with newly diagnosed stage IIIB/IV NSCLC in Spain (predominantly Caucasian ethnicity).
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- To be recruited by Oncologist
Key inclusion criteria (2 listed)
- Signed written informed consent
- Histologically confirmed locally advanced or metastatic NSCLC (stage IIIB/IV)
Key exclusion criteria (1 listed)
- Mixed histology of small cell and non-small cell lung cancer
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
To estimate the prevalence of EGFR mutation in a representative sample of patients with newly diagnosed stage IIIB/IV NSCLC in Spain (predominantly Caucasian ethnicity).
3 secondary outcomes
Correlate EGFR mutation status with clinico-pathological characteristics. The study will aim to determine the prevalence of EGFR M+ lung cancers in patients with clinico-pathological characteristics not commonly associated with EGFR mutation positivity
To describe different EGFR mutation methods used in Spain and testing turn around time associated
To determine the % of confirmed stage IIIB/IV NSCLC patients who cannot be tested for EGFR mutation and the reasons for not testing (% of EGFR Mnt)
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 16 Mar 2011.
- Derived from this study: PubMed 25766256Esteban E, Majem M, Martinez Aguillo M, Martinez Banaclocha N, Domine M, Gomez Aldaravi L, Juan O, Cajal R, Gonzalez Arenas MC, Provencio M. Prevalence of EGFR mutations in newly diagnosed locally advanced or metastatic non-small cell lung cancer Spanish patients and its association with histological subtypes and clinical features: The Spanish REASON study. Cancer Epidemiol. 2015 Jun;39(3):291-7. doi: 10.1016/j.canep.2015.02.003. Epub 2015 Mar 9.
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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.
Carmen Gonzalez Arenas study director
Medical Department. Mediclin-AstraZeneca. Spain
24 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 AstraZeneca at 24 sites in Spain.
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 2 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 16 Mar 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 24 sites in Spain. 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?
To estimate the prevalence of EGFR mutation in a representative sample of patients with newly diagnosed stage IIIB/IV NSCLC in Spain (predominantly Caucasian ethnicity).. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01081496, which also lists 1 linked publication.
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 16 Mar 2011.