Descriptive Pharmacoepidemiological Study of Patients Treated With Iressa

NCT ID: NCT01448187

Last Updated: 2016-07-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

361 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-01-31

Study Completion Date

2015-03-31

Brief Summary

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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

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Descriptive pharmacoepidemiological study of patients treated with Iressa

Conditions

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Lung Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* Patients treated with Iressa

Exclusion Criteria

* 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
Maximum Eligible Age

130 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Thierry BOUILLET, Dr

Role: PRINCIPAL_INVESTIGATOR

Bobigny

Elisabeth BRAMBILLA, Pr

Role: PRINCIPAL_INVESTIGATOR

Grenoble

Jacques CADRANEL, Pr

Role: PRINCIPAL_INVESTIGATOR

Paris

Jean-Francois MORERE, Pr

Role: PRINCIPAL_INVESTIGATOR

Bobigny

Maurice PEROL, Dr

Role: PRINCIPAL_INVESTIGATOR

Lyon

Virginie RONDEAU, PhD

Role: PRINCIPAL_INVESTIGATOR

Bordeaux

Locations

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Research Site

Aulnay-sous-Bois, , France

Site Status

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Bayonne, , France

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Bordeaux, , France

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Bron, , France

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Carcassonne, , France

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Chalon-sur-Saône, , France

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Cholet, , France

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Clamart, , France

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Colmar, , France

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Corbeil-Essonnes, , France

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Créteil, , France

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Épernay, , France

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La Source, , France

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Marseille, , France

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Mâcon, , France

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Metz, , France

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Mont-de-Marsan, , France

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Niort, , France

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Paris, , France

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Pierre-Bénite, , France

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Quimper, , France

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Reims, , France

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Rouen, , France

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Saint-Herblain, , France

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Saint-Nazaire, , France

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Saint-Omer, , France

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Strasbourg, , France

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Toulon, , France

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Vienne, , France

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Countries

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France

Related Links

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Other Identifiers

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NIS-OFR-IRE-2011/1

Identifier Type: -

Identifier Source: org_study_id

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