Newly Diagnosed Locally Advanced or Metastatic Non-small Cell Lung CancerREASONNCT00997230

Epidemiological and Scientific Evaluation of EGFR Mutation Status in Patients With Newly Diagnosed Locally Advanced or m

An observational study of Newly Diagnosed Locally Advanced or Metastatic Non-small Cell Lung Cancer, run by AstraZeneca at 118 sites in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Newly Diagnosed Locally Advanced or Metastatic Non-small Cell Lung Cancer
How many people: 4,243 participants
Where: 118 sitesGermany
Study dates: Sep 2009to Oct 2012
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: clinical setting

Histologically confirmed locally advanced or metastatic NSCLC (stage IIIB/IV). Mixed histology of small cell and non-small cell lung cancer

Trial locations and contacts

118 sites in 1 country.

City, postcode or hospital

118 sites in 1 country

Germany118 sites

Research Site
Aachen
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Amberg
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Ansbach
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Aschaffenburg
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Augsburg
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Bad Berka
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Ballenstedt
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Bamberg
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Bayreuth
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Berlin
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Bielefeld
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Bitterfeld-Wolfen
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Bochum
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Bonn
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Borstel
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Bottrop
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Braunschweig
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Bremen
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Bremerhaven
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Celle
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Chemnitz
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Cologne
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Coswig
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Cottbus
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Darmstadt
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Deggendorf
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Dessau
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Donaustauf
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Dortmund
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Dresden
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Düsseldorf
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Eisenach
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Erlangen
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Essen
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Esslingen am Neckar
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Flensburg
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Frankfurt
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Freiburg im Breisgau
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Freising
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Fulda
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Gerlingen
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Gieben
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Goslar
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Göttingen
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Greifenstein
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Grobhansdorf
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Halle
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Halle-Dolau
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Hamburg
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Hamm
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Hanover
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Heidelberg
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Hemer
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Hof
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Homburg
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Immenhausen
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Jena
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Karlsruhe
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Kassel
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Kiel
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Koblenz
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Landshut
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Leipzig
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Lemgo
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Leverkusen
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Lostau
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Löwenstein
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Lübeck
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Ludwigshafen
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Lüneburg
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Lünen
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Magdeburg
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Mainz
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Mannheim
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Marburg
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Minden
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Moers
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Mülheim
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München
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Münnerstadt
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Münster
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Neuss
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Nordhausen
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Northeim
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Nuremberg
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Oberhausen
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Offenbach
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Offenburg
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Oldenburg
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Osnabrück
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Ostfildern
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Paderborn
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Passau
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Querfurt
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Recklinghausen
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Regensburg
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Rosenheim
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Rostock
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Saarbrücken
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Schönebeck
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Solingen
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Sonneberg
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Stralsund
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Stuttgart
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Suhl
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Treuenbrietzen
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Trier
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Tübingen
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Ulm
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Velbert
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Villingen-Schwenningen
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Völklingen
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Wangen/Allgau
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Weiden
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Wiesbaden
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Würselen
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Würzburg
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Zusmarshausen

Other trials in Germany

About this study

Official title: An NIS Registry for the Epidemiological and Scientific Evaluation of EGFR Mutation Status in Patients With Newly Diagnosed Locally Advanced or Metastatic Non-small Cell Lung Cancer (Stage IIIB/IV Non-small Cell Lung Cancer)

The primary objective of the study is to collect epidemiological data on EGFR mutation status (M+, M-) in a population of predominantly Caucasian ethnicity and to correlate EGFR mutation status with clinico-pathological characteristics (e.g. smoking status, sex, histology, etc). In particular, the study will aim to determine the frequency of EGFR M+ lung cancers in patients with clinico-pathological characteristics that are not commonly associated with EGFR mutation positivity (i.e., smokers, men, and non-adenocarcinoma).

Read the detailed description

An NIS Registry for the Epidemiological and Scientific evaluation of EGFR mutation status in patients with newly diagnosed locally advanced or metastatic NSCLC (stage IIIB/IV non-small cell lung cancer)

Conditions: Newly Diagnosed Locally Advanced or Metastatic Non-small Cell Lung Cancer
Keywords: EGFR mutation ,newly diagnosed NSCLC, 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.

The primary objective of the study is to collect epidemiological data on EGFR mutation status (M+, M-) in a population of predominantly Caucasian ethnicity and to correlate EGFR mutation status with clinico-pathological characteristics
Measured: Days 1-10

Secondary outcomes (1)

To collect real-life clinical outcome data in all EGFR M+ patients up to and including progression.To collect real-life pharmacoeconomic data (resource use) associated with the diagnosis and treatment of EGFR M+ patients.
Measured: Study Days 21-30

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Sep 2009Oct 2012

First posted19 Oct 2009 (estimated)
Study startSep 2009
Primary completionOct 2012
Study completionOct 2012

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 Newly Diagnosed Locally Advanced or Metastatic 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: Case only
Time perspective: Prospective
Enrolment: 4,243 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00997230
Sponsor's protocol ID: NIS-ODE-DUM-2009/1
Acronym: REASON
Status last verified: Oct 2013
First submitted: 16 Oct 2009
Last updated: 28 Oct 2013
Results posted: No
Data monitoring committee: No

Publications

Schuette W, Schirmacher P, Eberhardt WEE, Dietel M, Zirrgiebel U, Muehlenhoff L, Thomas M. Treatment decisions, clinical outcomes, and pharmacoeconomics in the treatment of patients with EGFR mutated stage III/IV NSCLC in Germany: an observational study. BMC Cancer. 2018 Feb 5;18(1):135. doi: 10.1186/s12885-018-4032-3.
PubMed 29402243

Study at a glance

From the registry record, last updated by the sponsor on 28 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An NIS Registry for the Epidemiological and Scientific Evaluation of EGFR Mutation Status in Patients With Newly Diagnosed Locally Advanced or Metastatic Non-small Cell Lung Cancer (Stage IIIB/IV Non-small Cell Lung Cancer)
ClinicalTrials.gov ID: NCT00997230
Acronym / sponsor ID: REASON / NIS-ODE-DUM-2009/1
Conditions: Newly Diagnosed Locally Advanced or Metastatic Non-small Cell Lung Cancer
Keywords: EGFR mutation ,newly diagnosed NSCLC, locally advanced or metastatic NSCLC
Study type: Observational
Recruitment status: Completed
Enrolment: 4,243 participants (actual)
Lead sponsor: AstraZenecaIndustry (pharma, biotech, devices)
Study start: Sep 2009
Primary completion: Oct 2012 (actual)
Study completion: Oct 2012 (actual)
First posted: 19 Oct 2009 (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.

Detailed description

Study design

Observational model: Case only
Time perspective: Prospective

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: clinical setting

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

The primary objective of the study is to collect epidemiological data on EGFR mutation status (M+, M-) in a population of predominantly Caucasian ethnicity and to correlate EGFR mutation status with clinico-pathological characteristics
Time frame: Days 1-10

1 secondary outcome

To collect real-life clinical outcome data in all EGFR M+ patients up to and including progression.To collect real-life pharmacoeconomic data (resource use) associated with the diagnosis and treatment of EGFR M+ patients.
Time frame: Study Days 21-30

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 28 Oct 2013.
Derived from this study: PubMed 29402243Schuette W, Schirmacher P, Eberhardt WEE, Dietel M, Zirrgiebel U, Muehlenhoff L, Thomas M. Treatment decisions, clinical outcomes, and pharmacoeconomics in the treatment of patients with EGFR mutated stage III/IV NSCLC in Germany: an observational study. BMC Cancer. 2018 Feb 5;18(1):135. doi: 10.1186/s12885-018-4032-3.

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.

Prof. Dr. H. Brasch study director

AstraZeneca Germany

PD Dr. med. Wolfgang Schutte principal investigator

06120 Halle-Dolau, Germany

118 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Newly Diagnosed Locally Advanced or Metastatic Non-small Cell Lung Cancer, run by AstraZeneca at 118 sites in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

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 28 Oct 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 118 sites in Germany. 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?

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00997230, 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 28 Oct 2013.