Lung CancerEPIDAURENCT01448187
Descriptive Pharmacoepidemiological Study of Patients Treated With Iressa
An observational study of Lung Cancer, run by AstraZeneca at 29 sites in France.
Trial summary
The aim of the study is to describe the characteristics of patients treated with Iressa (particularly age, gender, phenotype, histology and stage of disease, line of treatment and previous treatments, smoking history, conditions of initiation of treatment (presence of an EGFR-activating mutation) and to evaluate the… Read more about this study
- Who is it for?
- Ages Up to 130 years
- Conditions the study is for
- Lung Cancer
- How many people
- 361 participants
- Where
- 29 sitesFrance
- Study dates
- Jan 2012to Mar 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 Up to 130 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Hospital, clinic
Who may be able to join
- Patients treated with Iressa
Who cannot join
- Patient included in a therapeutic trial comprising protocol use of Iressa
- Patient included in a therapeutic trial (Huriet-Serusclat Act)
- Patient refusing to participate in the study
Trial locations and contacts
29 sites in 1 country.
29 sites in 1 country
France29 sites
Research Site
Aulnay-sous-Bois
Research Site
Bayonne
Research Site
Bordeaux
Research Site
Bron
Research Site
Carcassonne
Research Site
Chalon-sur-Saône
Research Site
Cholet
Research Site
Clamart
Research Site
Colmar
Research Site
Corbeil-Essonnes
Research Site
Créteil
Research Site
Épernay
Research Site
La Source
Research Site
Mâcon
Research Site
Marseille
Reseacrh Site
Metz
Research Site
Mont-de-Marsan
Research Site
Niort
Research Site
Paris
Research Site
Pierre-Bénite
Research Site
Quimper
Research Site
Reims
Research Site
Rouen
Research Site
Saint-Herblain
Research Site
Saint-Nazaire
Research Site
Saint-Omer
Research Site
Strasbourg
Research Site
Toulon
Research Site
Vienne
About this study
The aim of the study is to describe the characteristics of patients treated with Iressa (particularly age, gender, phenotype, histology and stage of disease, line of treatment and previous treatments, smoking history, conditions of initiation of treatment (presence of an EGFR-activating mutation) and to evaluate the impact of treatment on the health of the population concerned in terms of morbidity and mortality (clinical benefit, safety,...) and quality of life
Read the detailed description
Descriptive pharmacoepidemiological study of patients treated with Iressa
- Conditions
- Lung Cancer
- Keywords
- Lung cancer, France
- Medical subject headings
- Lung Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
The Overall survival
Measured: 24 months
The progression free survival
Measured: 24 months
Secondary outcomes (6)
Description of Quality of life by Functional Assessment of Cancer Therapy - Lung including Life Stressor Checklist (FACT-L including LSC)
Measured: baseline
Description of Quality of life by Functional Assessment of Cancer Therapy - Lung including Life Stressor Checklist (FACT-L including LSC)
Measured: From baseline to 3 months
Description of Quality of life by Life Stressor Checklist - Lung (LSC-L)
Measured: From 3 months to 6 months
Description of Quality of life by Life Stressor Checklist - Lung (LSC-L)
Measured: From 6 months to 12 months
Description of Quality of life by Life Stressor Checklist - Lung (LSC-L)
Measured: From 12 months to 18 months
Description of Quality of life by Life Stressor Checklist - Lung (LSC-L)
Measured: From 18 months to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2011 (estimated)
- Study startJan 2012
- Primary completionMar 2015
- Study completionMar 2015
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 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
- 361 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Thierry BOUILLET, Dr, Principal investigator, BobignyElisabeth BRAMBILLA, Pr, Principal investigator, GrenobleJacques CADRANEL, Pr, Principal investigator, ParisJean-Francois MORERE, Pr, Principal investigator, BobignyMaurice PEROL, Dr, Principal investigator, LyonVirginie RONDEAU, PhD, Principal investigator, Bordeaux
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01448187
- Sponsor's protocol ID
- NIS-OFR-IRE-2011/1
- Acronym
- EPIDAURE
- Status last verified
- Jul 2016
- First submitted
- 26 Sep 2011
- Last updated
- 4 Jul 2016
- Results posted
- No
- Data monitoring committee
- 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
- Descriptive Pharmacoepidemiological Study of Patients Treated With Iressa
- ClinicalTrials.gov ID
- NCT01448187
- Acronym / sponsor ID
- EPIDAURE / NIS-OFR-IRE-2011/1
- Conditions
- Lung Cancer
- Keywords
- Lung cancer, France
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 361 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Jan 2012
- Primary completion
- Mar 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 7 Oct 2011 (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.
The aim of the study is to describe the characteristics of patients treated with Iressa (particularly age, gender, phenotype, histology and stage of disease, line of treatment and previous treatments, smoking history, conditions of initiation of treatment (presence of an EGFR-activating mutation) and to evaluate the impact of treatment on the health of the population concerned in terms of morbidity and mortality (clinical benefit, safety,...) and quality of life
Detailed description
Descriptive pharmacoepidemiological study of patients treated with Iressa
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- Up to 130 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Hospital, clinic
Key inclusion criteria (1 listed)
- Patients treated with Iressa
Key exclusion criteria (3 listed)
- Patient included in a therapeutic trial comprising protocol use of Iressa
- Patient included in a therapeutic trial (Huriet-Serusclat Act)
- Patient refusing to participate in the study
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 Overall survival
Time frame: 24 months
The progression free survival
Time frame: 24 months
6 secondary outcomes
Description of Quality of life by Functional Assessment of Cancer Therapy - Lung including Life Stressor Checklist (FACT-L including LSC)
Time frame: baseline
Description of Quality of life by Functional Assessment of Cancer Therapy - Lung including Life Stressor Checklist (FACT-L including LSC)
Time frame: From baseline to 3 months
Description of Quality of life by Life Stressor Checklist - Lung (LSC-L)
Time frame: From 3 months to 6 months
Description of Quality of life by Life Stressor Checklist - Lung (LSC-L)
Time frame: From 6 months to 12 months
Description of Quality of life by Life Stressor Checklist - Lung (LSC-L)
Time frame: From 12 months to 18 months
Description of Quality of life by Life Stressor Checklist - Lung (LSC-L)
Time frame: From 18 months to 24 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 4 Jul 2016.
- NIS-OFR-IRE-2011\_1CSR\_Synopsis.pdfLink provided by the sponsor.
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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.
Thierry BOUILLET, Dr principal investigator
Bobigny
Elisabeth BRAMBILLA, Pr principal investigator
Grenoble
Jacques CADRANEL, Pr principal investigator
Paris
29 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Cancer, run by AstraZeneca at 29 sites in France.
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 1 inclusion and 3 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 29 sites in France. 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?
The Overall survival (time frame: 24 months). The study lists 2 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 4 Jul 2016.