Descriptive Observational Study ALK-2016-CPHG

NCT ID: NCT03718117

Last Updated: 2024-09-27

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

73 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-01-03

Study Completion Date

2020-07-01

Brief Summary

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Descriptive Observational Study.

Characteristics Of ALK-positive and ROS1-positive Adults Patients Non-Small Cell Lung Cancer (NSCLC) Treated With Crizotinib Within General Hospitals

Detailed Description

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Describe the characteristics of patients treated with crizotinib Describe efficacy, safety, observance and QoL.

Conditions

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NSCLC Crizotinib ALK Gene Rearrangement or ROS1 Gene Rearrangement

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* Age ≥ 18 years
* Locally advanced or metastatic NSCLC
* Patient ALK gene rearrangement or ROS1 gene rearrangement
* Patient having initiated in the previous 3 months or patient initiating crizotinib treatment regardless of the line of treatment
* Patient followed up by a physician in a hospital pulmonary medicine department
* Subject of reproductive age, using an effective method of contraception
* Patient informed verbally and in writing on the study and having consented to his/her personal data being collected within the scope of the study.


* Patient included within the scope of an interventional therapeutic trial
* Patient not presenting with ALK gene rearrangement or ROS1 gene rearrangement
* Patient not available for follow-up throughout the duration of the study
* Patient deemed to be incapable of responding to the study questions for linguistic, cognitive or organisational reasons.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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French College of General Hospital Pneumologists (CPHG)

OTHER

Sponsor Role collaborator

Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Centre Hospitalier Intercommunal du Pays d'Aix-Pertuis,Service de Pneumologie

Aix-en-Provence, , France

Site Status

Clinique de l Europe

Amiens, , France

Site Status

Hopital Robert Ballanger, Service de Pneumologie

Aulnay-sous-Bois, , France

Site Status

Centre Hospitalier d Avignon

Avignon, , France

Site Status

Centre Hospitalier de Beauvais

Beauvais, , France

Site Status

Centre Hospitalier General Beziers, Service De Pneumologie

Béziers, , France

Site Status

Centre Hospitalier de Cannes

Cannes, , France

Site Status

Centre Hospitalier Chalon sur Saone William Morey

Chalon-sur-Saône, , France

Site Status

Centre Hospitalier Metropole de Savoie-Site de Chambery

Chambéry, , France

Site Status

Hopitaux Civils de Colmar - Hopital Louis Pasteur

Colmar, , France

Site Status

Centre Hospitalier ALPES LEMAN

Contamine-sur-Arve, , France

Site Status

Centre Hospitalier Intercommunal Frejus

Fréjus, , France

Site Status

Centre Hospitalier Départemental Les Oudairies

La Roche-sur-Yon, , France

Site Status

CHD Vendee

La Roche-sur-Yon, , France

Site Status

Le Mans Hospital Center

Le Mans, , France

Site Status

Centre Hospitalier des Deux Vallees - Longjumeau BP 125

Longjumeau, , France

Site Status

Hopital Europeen - Service de Pneumologie

Marseille, , France

Site Status

Centre Hospitalier de Macon

Mâcon, , France

Site Status

GHR Mulhouse Sud Alsace

Mulhouse, , France

Site Status

Centre Hospitalier de l'Agglomeration de Nevers

Nevers, , France

Site Status

Centre Hospitalier Regional d Orleans

Orléans, , France

Site Status

Centre Hospitalier Annecy Genevois

Pringy, , France

Site Status

Groupe Hospitalier Sud Reunion

Saint Pierre La Réunion, , France

Site Status

Hopitaux du Leman

Thonon-les-Bains, , France

Site Status

Centre Hospitalier de Troyes, Service de Pneumologie - Oncologie Thoracique

Troyes, , France

Site Status

Centre Hospitalier de Villefranche sur Saone - BP80436

Villefranche-sur-Saône, , France

Site Status

Countries

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France

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

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https://pmiform.com/clinical-trial-info-request?StudyID=A8081060

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Other Identifiers

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ALK-2016-CPHG

Identifier Type: OTHER

Identifier Source: secondary_id

A8081060

Identifier Type: -

Identifier Source: org_study_id

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