NSCLCEPICLINNCT00831909

Epidemiological Study to Describe NSCLC Clinical Management Patterns in Europe. Lung-EPICLIN

An observational study of NSCLC, run by AstraZeneca at 162 sites in 8 countries.

Completed

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

Trial summary

To provide accurate and reliable information regarding NSCLC clinical management across European countries 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… Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: NSCLC
How many people: 3,513 participants
Where: 162 sitesin 8 countries
Study dates: Jan 2009to Jul 2010
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: All NSCLC patients attending the responsible department of treating this type of patients (e.g. Oncology Department, Pneumology Department) for the first time (regardless of whether the patient is diagnosed with locally, advanced or metastatic disease) at the participating sites from the first of January 2009 to the end of March 2009. Patients diagnosed, or even treated, in other departments within the same hospital or in another hospital are susceptible to be included in the study if full access to the patient's medical record is made available.

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 January 1st, 2009 and March 31st, 2009.
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 external validity and to obtain the most accurate real daily practice information.

Trial locations and contacts

162 sites in 8 countries.

Country

City, postcode or hospital

162 sites in 8 countries

France76 sites

Research Site
Aix-en-Provence
Research Site
Ambilly
Research Site
Antibes
Research Site
Aulnay-sous-Bois
Research Site
Bar-le-Duc
Research Site
Beauvais
Research Site
Beuvry
Research Site
Bordeaux
Research Site
Brest
Research Site
Cahors
Research Site
Castelnau-le-Lez
Research Site
Chalon-sur-Saône
Research Site
Chauny
Research Site
Chevilly-Larue
Research Site
Cholet
Research Site
Clamart
Research Site
Colmar
Research Site
Compiègne
Research Site
Coulommiers
Research Site
Denain
Research Site
Dijon
Research Site
Douai
Research Site
Draguignan
Research Site
Épinal
Research Site
Flers
Research Site
Givors
Research Site
Granville
Research Site
Grasse
Research Site
Guingamp
Research Site
Hyères
Research Site
Jonzac
Research Site
La Ferté-Bernard
Research Site
La Rochelle
Research Site
La Tronche
Research Site
Le Mans
Research Site
Liévin
Research Site
Limoges
Research Site
Longjumeau
Research Site
Lyon
Research Site
Mantes-la-Jolie
Research Site
Martigues
Research Site
Meaux
Research Site
Metz
Research Site
Metz-Tessy
Research Site
Mont-de-Marsan
Research Site
Mont-Saint-Martin
Research Site
Montpellier
Research Site
Moulins
Research Site
Mulhouse
Research Site
Nancy
Research Site
Nevers
Research Site
Nice
Research Site
Nîmes
Research Site
Oloron-Sainte-Marie
Research Site
Paris
Research Site
Perpignan
Research Site
Pierre-Bénite
Research Site
Pontoise
Research Site
Quimper
Research Site
Rambouillet
Research Site
Reims
Research Site
Rennes
Research Site
Saint-Aubin-lès-Elbeuf
Research Site
Saint-Priest-en-Jarez
Research Site
Saverne
Research Site
Soissons
Research Site
Strasbourg
Research Site
Thonon-les-Bains
Research Site
Toulon
Research Site
Toulon Armees
Research Site
Toulouse
Research Site
Valence
Research Site
Vandœuvre-lès-Nancy
Research Site
Verdun
Research Site
Vesoul
Research Site
Vire

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Spain31 sites

Research Site
A Coruña
Research Site
Alicante
Research Site
Barcelona
Research Site
Cabueñes
Research Site
Calella
Research Site
Castellon
Research Site
Córdoba
Research Site
Cuenca
Research Site
Elche
Research Site
Jaén
Research Site
León
Research Site
Lleida
Research Site
Madrid, Madrid
Research Site
Madrid
Research Site
Málaga
Research Site
Manacor
Research Site
Mataró
Research Site
Melilla
Research Site
Oviedo
Research Site
Palma de Mallorca
Research Site
Pamplona
Research Site
Puerto Real
Research Site
Sagunto
Research Site
Salamanca
Research Site
Santa Cruz de Tenerife, Tenerife
Research Site
Santa Cruz de Tenerife
Research Site
Seville
Research Site
Tudela
Research Site
Valencia
Research Site
Xàtiva
Research Site
Zaragoza

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Italy23 sites

Research Site
Bologna
Research Site
Brindisi
Research Site
Carpi
Research Site
Cattolica
Research Site
Cesena
Research Site
Cremona
Research Site
Faenza
Research Site
Fano
Research Site
Legnano
Research Site
Lido di Camaiore
Research Site
Lugo
Research Site
Mantua
Research Site
Meldola
Research Site
Milan
Research Site
Naples
Research Site
Parma
Research Site
Perugia
Research Site
Ravenna
Research Site
Rimini
Research Site
S. Giovanni Rotondo
Research Site
Saronno
Research Site
Sondrio
Research Site
Verona

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Germany10 sites

Research Site
Essen, North Rhine-Westphalia
Research Site
Gro�hansdorf, Schleswig-Holstein
Research Site
Halle, Saxony-Anhalt
Research Site
Harburg, Free and Hanseatic City of Hamburg
Research Site
Heidelberg, Baden W�rttemberg
Research Site
Hemer, North Rhine-Westphalia
Research Site
Leipzig, Saxony
Research Site
Löwenstein, Baden-W�rttemberg
Research Site
Munchen-Gauting, Bavaria
Research Site
Ulm, Baden-W�rtemberg

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Greece6 sites

Research Site
Athens, Athens
Research Site
Heraklio, Crete
Research Site
Ioannina, Ioannina
Research Site
Pátrai, Patra
Research Site
Piraeus, Piraeus
Research Site
Thessaloniki, Thessaloniki

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Turkey (Türkiye)6 sites

Research Site
Adana
Research Site
Ankara
Research Site
Gaziantep
Research Site
Istanbul
Research Site
Izmir
Research Site
Konya

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Belgium5 sites

Research Site
Antwerp
Research Site
Brussels
Research Site
Genk
Research Site
Herstal
Research Site
Liège

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Portugal5 sites

Research Site
Lisbon
Research Site
Ponta Delgada
Research Site
Porto
Research Site
Sta.Ma Feira
Research Site
V.N: de Gaia

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About this study

Official title: Epidemiological Study to Describe Non-small Cell Lung Cancer (NSCLC) Clinical Management Patterns in Europe. Lung

Conditions: NSCLC
Keywords: Lung Cancer, NSCLC management, NSCLC use of health care resources
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 groups in NCT00831909
Study group	Role	What they receive
1		All NSCLC patients attending the responsible department of treating this type of patients (e.g. Oncology Department, Pneumology Department) for the first time (regardless of whether the patient is diagnosed with locally, advanced or metastatic disease) at the participating sites from the first of January 2009 to the end of March 2009. Patients diagnosed, or even treated, in other departments within the same hospital or in another hospital are susceptible to be included in the study if full access to the patient's medical record is made available.

What is being measured

The primary outcome is the main question the study is designed to answer.

To provide accurate, reliable information on NSCLC clinical management across European countries in order to detect unmet medical needs of this disease
Measured: 1 year follow up

Secondary outcomes (5)

To assess the differences in patient characteristics, disease stage (differentiating between non-advanced disease, locally advanced disease, metastatic disease), and in clinical management across European countries.
Measured: 1 year follow up
To detect differences in clinical outcomes and related factors among countries.
Measured: 1 year follow up
To identify factors associated with clinical outcomes (patient, disease stage and clinical management related factors): predictive modelling for improved patient outcome.
Measured: 1 year follow up
To identify factors associated with the different levels of functional status and quality of life.
Measured: 1 year follow up
To compare the use of health care resources among countries.
Measured: 1 year follow up

Timeline

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

Jan 2009Jul 2010

First posted29 Jan 2009 (estimated)
Study startJan 2009
Primary completionJul 2010
Study completionJul 2010

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (2)Papers the sponsor has linked to this study.
Other trials for NSCLCStudies 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: Prospective
Enrolment: 3,513 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00831909
Sponsor's protocol ID: NIS-OEU-DUM-2008/1
Acronym: EPICLIN
Status last verified: Aug 2010
First submitted: 28 Jan 2009
Last updated: 10 Aug 2010
Results posted: No
Data monitoring committee: No

Publications

Vergnenegre A, Carrato A, Thomas M, Jernigan C, Medina J, Cruciani G. Real-world healthcare resource utilization in a European non-small cell lung cancer population: the EPICLIN-Lung study. Curr Med Res Opin. 2014 Mar;30(3):463-70. doi: 10.1185/03007995.2013.860373. Epub 2013 Nov 18.
PubMed 24188056
Carrato A, Vergnenegre A, Thomas M, McBride K, Medina J, Cruciani G. Clinical management patterns and treatment outcomes in patients with non-small cell lung cancer (NSCLC) across Europe: EPICLIN-Lung study. Curr Med Res Opin. 2014 Mar;30(3):447-61. doi: 10.1185/03007995.2013.860372. Epub 2013 Nov 18.
PubMed 24168104

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 1/2
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A Prospective ,Multicenter ,Non-interventional ,Real-world Study Observing Changes in Molecular Markers Osimertinib Targeted Therapy in EGFRm NSCLC
Non Small Cell Lung Cancer
RecruitingPhase 3
A Study Evaluating Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Participants With Stage IV or Advanced Stage IIIB/C Nonsquamous Non-Small Cell Lung Cancers (CodeBreaK 202)
Non-Small Cell Lung Cancer (NSCLC)
Active, not recruitingPhase 2
Datopotamab Deruxtecan (Dato-DXd, DS-1062a) in Advanced and/or Unresectable Non-Small Cell Lung Cancer
Metastatic Lung Cancer, Advanced Non Small Cell Lung Cancer
Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer

All NSCLC trials

Study at a glance

From the registry record, last updated by the sponsor on 10 Aug 2010. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Epidemiological Study to Describe Non-small Cell Lung Cancer (NSCLC) Clinical Management Patterns in Europe. Lung
ClinicalTrials.gov ID: NCT00831909
Acronym / sponsor ID: EPICLIN / NIS-OEU-DUM-2008/1
Conditions: NSCLC
Keywords: Lung Cancer, NSCLC management, NSCLC use of health care resources
Study type: Observational
Recruitment status: Completed
Enrolment: 3,513 participants (actual)
Lead sponsor: AstraZenecaIndustry (pharma, biotech, devices)
Study start: Jan 2009
Primary completion: Jul 2010 (actual)
Study completion: Jul 2010 (actual)
First posted: 29 Jan 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.

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
1	–	–All NSCLC patients attending the responsible department of treating this type of patients (e.g. Oncology Department, Pneumology Department) for the first time (regardless of whether the patient is diagnosed with locally, advanced or metastatic disease) at the participating sites from the first of January 2009 to the end of March 2009. Patients diagnosed, or even treated, in other departments within the same hospital or in another hospital are susceptible to be included in the study if full access to the patient's medical record is made available.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: All NSCLC patients attending the responsible department of treating this type of patients (e.g. Oncology Department, Pneumology Department) for the first time (regardless of whether the patient is diagnosed with locally, advanced or metastatic disease) at the participating sites from the first of January 2009 to the end of March 2009. Patients diagnosed, or even treated, in other departments within the same hospital or in another hospital are susceptible to be included in the study if full access to the patient's medical record is made available.

Key inclusion criteria (2 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 January 1st, 2009 and March 31st, 2009.
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.

Key exclusion criteria (1 listed)

According to the study design there will not be any exclusion criteria in order to provide a high external 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

To provide accurate, reliable information on NSCLC clinical management across European countries in order to detect unmet medical needs of this disease
Time frame: 1 year follow up

5 secondary outcomes

To assess the differences in patient characteristics, disease stage (differentiating between non-advanced disease, locally advanced disease, metastatic disease), and in clinical management across European countries.
Time frame: 1 year follow up
To detect differences in clinical outcomes and related factors among countries.
Time frame: 1 year follow up
To identify factors associated with clinical outcomes (patient, disease stage and clinical management related factors): predictive modelling for improved patient outcome.
Time frame: 1 year follow up
To identify factors associated with the different levels of functional status and quality of life.
Time frame: 1 year follow up
To compare the use of health care resources among countries.
Time frame: 1 year follow up

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 10 Aug 2010.
Derived from this study: PubMed 24188056Vergnenegre A, Carrato A, Thomas M, Jernigan C, Medina J, Cruciani G. Real-world healthcare resource utilization in a European non-small cell lung cancer population: the EPICLIN-Lung study. Curr Med Res Opin. 2014 Mar;30(3):463-70. doi: 10.1185/03007995.2013.860373. Epub 2013 Nov 18.
Derived from this study: PubMed 24168104Carrato A, Vergnenegre A, Thomas M, McBride K, Medina J, Cruciani G. Clinical management patterns and treatment outcomes in patients with non-small cell lung cancer (NSCLC) across Europe: EPICLIN-Lung study. Curr Med Res Opin. 2014 Mar;30(3):447-61. doi: 10.1185/03007995.2013.860372. Epub 2013 Nov 18.

Related trials for NSCLC

RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
A Prospective ,Multicenter ,Non-interventional ,Real-world Study Observing Changes in Molecular Markers Osimertinib Targeted Therapy in EGFRm NSCLC
Non Small Cell Lung Cancer
RecruitingPhase 3
A Study Evaluating Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Participants With Stage IV or Advanced Stage IIIB/C Nonsquamous Non-Small Cell Lung Cancers (CodeBreaK 202)
Non-Small Cell Lung Cancer (NSCLC)
Active, not recruitingPhase 2
Datopotamab Deruxtecan (Dato-DXd, DS-1062a) in Advanced and/or Unresectable Non-Small Cell Lung Cancer
Metastatic Lung Cancer, Advanced Non Small Cell Lung Cancer
Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer

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.

Alfredo Carrato, MD principal investigator

Hospital Ramón y Cajal, Madrid (Spain)

Esteban Medina study director

Medical Department, AstraZeneca Spain

162 sites in 8 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of NSCLC, run by AstraZeneca at 162 sites in 8 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 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 10 Aug 2010. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 162 sites in France, Spain, Italy, Germany, Greece and 3 more countries. 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 provide accurate, reliable information on NSCLC clinical management across European countries in order to detect unmet medical needs of this disease (time frame: 1 year follow up). 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 NCT00831909, which also lists 2 linked publications.

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 10 Aug 2010.