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Use of Biosimilar Nivestim® to Prevent Chemo-induced Neutropenia. Real Life Study

NCT ID: NCT02454530

Last Updated: 2019-06-28

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

1160 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-09-30

Study Completion Date

2017-01-31

Brief Summary

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The aim of this study is to describe in real-life conditions the determinants of use of GCSF (Granulocyte Colony-Stimulating Factor) Nivestim® in primary or secondary prophylaxis and in patients receiving chemotherapy for solid tumour according to the chemotherapy context: adjuvant or metastatic setting.

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Detailed Description

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This is a longitudinal, observational, prospective, multicentre, cohort study, conducted in France among a representative sample of public and/or private hospital-based oncologists.

Data will be collected by the investigator during three visits using data available in the patient medical record and obtained from patient questioning and clinical examination performed during the consultations:

* Baseline visit: prescription of Nivestim®.
* Follow-up visit: during the first cycle of chemotherapy after the first course of Nivestim®.
* Final visit: after the last cycle of chemotherapy or 16-18 weeks after inclusion.

Conditions

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Chemotherapy-Induced Neutropenia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Cancer patients treated with Nivestim®

Nivestim®

Intervention Type BIOLOGICAL

Interventions

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Nivestim®

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* Patients aged at least 18 years, seen by the oncologist for chemotherapy for solid tumour.
* Patients for whom the oncologist has decided the initiation of G-CSF biosimilar treatment (Nivestim®) in primary or secondary prophylaxis.
* Patients informed about the computer processing of their medical data and their right of access and correction.

Exclusion Criteria

* Patients with contraindication of use of Nivestim®.
* Patients with haematological malignancy including Myelodysplasia and Chronic myeloid leukemia treated or untreated.
* Patients participating or having participated in the previous month in a clinical trial.
* Patients refusing to participate in this study.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospira, now a wholly owned subsidiary of Pfizer

INDUSTRY

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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Clinique Rambot La Provençale Tour d'Aygosi

Aix-en-Provence, , France

Site Status

Centre Hospitalier du Pays d'Aix Service d'Hématologie - Oncologie

Aix-en-Provence, , France

Site Status

ICO Centre Paul Papin Service d'Oncologie Médicale

Angers, , France

Site Status

CHU - Hôtel-Dieu Service Hépato-Gastro-entérologie

Angers, , France

Site Status

CH d'Armentières Service Oncologie

Armentières, , France

Site Status

Centre Marie Curie A l'attention de Laëtitia

Arras, , France

Site Status

Centre Hospitalier Service Oncologie

Auxerre, , France

Site Status

Clinique du Dr Maymard Service d'Oncologie

Bastia, , France

Site Status

Hôpital de Falconaja Furiani Service d'Oncologie

Bastia, , France

Site Status

Centre Hospitalier Philippe le Bon Service de Medecine Interne - 3e Etage

Beaune, , France

Site Status

CHU - Hôpital Jean Minjoz Service Oncologie Médicale

Besançon, , France

Site Status

Centre Hospitalier Service Onco-Hématologie

Béziers, , France

Site Status

Hôpital Avicenne Service Gastro-Entérologie

Bobigny, , France

Site Status

Clinique Tivoli

Bordeaux, , France

Site Status

Centre Hospitalier Service d'Oncologie

Boulogne-sur-Mer, , France

Site Status

CH de Fleyriat Service de Pneumologie

Bourg-en-Bresse, , France

Site Status

CH de Fleyriat Service Onco-Hématologie

Bourg-en-Bresse, , France

Site Status

Clinique Pasteur Lanroze Service Oncologie

Brest, , France

Site Status

Hôpital Augustin Morvan Institut de Cancérologie et d'Hématologie

Brest, , France

Site Status

Hôpital Morvan - CHU Institut de Cancérologie et d'Hématologie

Brest, , France

Site Status

Hôpital Louis Pradel Service Pneumologie - Centre des Maladies Orphelines

Bron, , France

Site Status

Centre François Baclesse Oncologie Médicale. Pathologie Mammaire et Recherche Clinique

Caen, , France

Site Status

Centre Hospitalier Service d'Oncologie

Carcassonne, , France

Site Status

Centre Hospitalier de Carcassonne Service d'Oncologie

Carcassonne, , France

Site Status

Medipole de Savoie Service Oncologie

Challes-les-Eaux, , France

Site Status

Médipole de Savoie

Challes-les-Eaux, , France

Site Status

CH William Morey Service d'Oncologie Médicale

Chalon-sur-Saône, , France

Site Status

CHP du Cotentin - Site de Cherbourg Service d'Oncologie

Cherbourg, , France

Site Status

Centre Hospitalier de Cholet Service d' Oncologie Médicale

Cholet, , France

Site Status

Centre Hospitalier de Cholet Service d'Hepato-Gastro-Enterologie

Cholet, , France

Site Status

Centre hospitalier Louis Pasteur Service de Pneumologie

Colmar, , France

Site Status

Hôpital Louis Pasteur Service de Pneumologie - Médecine F

Colmar, , France

Site Status

Centre de Radiothérapie GIE CROM

Compiègne, , France

Site Status

CHU de Dijon - Hôpital du Bocage Service Hépato-Gastro-Entérologie

Dijon, , France

Site Status

Centre Hospitalier de la Dracénie Service d'Oncologie

Draguignan, , France

Site Status

Centre Hospitalier de la Dracénie Service d'Oncologie

Draguignan, , France

Site Status

Centre Hospitalier Emile Durkheim Service Oncologie

Épinal, , France

Site Status

Clinique Chirurgicale Pasteur Service Oncologie Médicale

Évreux, , France

Site Status

CHI Fréjus Saint Raphaël Service d'Oncologie Médicale

Fréjus, , France

Site Status

CHI des Alpes du sud Site de Gap Muret Hôpital de Jour - Oncologie

Gap, , France

Site Status

Centre Hospitalier Service d'Oncologie

Gonesse, , France

Site Status

Centre Hospitalier Service Onco-Hématologie

Le Mans, , France

Site Status

Centre de Radiothérapie Hartmann

Levallois-Perret, , France

Site Status

Institut Franco Britannique Service Oncologie Médicale

Levallois-Perret, , France

Site Status

Clinique Hartman Service de Radiothérapie

Levallois-Perret, , France

Site Status

Clinique Hartmann Service Oncologie

Levallois-Perret, , France

Site Status

Centre de Radiothérapie Hartmann

Levallois-Perret, , France

Site Status

CHRU Lille - Hôpital Huriez Unité d'Oncologie Médicale

Lille, , France

Site Status

CHU Dupuytren Limoges Service d'Oncologie

Limoges, , France

Site Status

Centre Hospitalier Service de Médecine 2 - Hôpital de jour

Lons-le-Saunier, , France

Site Status

Centre Léon Bérard Service d'Oncologie Médicale

Lyon, , France

Site Status

Hôpital Privé Jean Mermoz Service d'Oncologie Médicale

Lyon, , France

Site Status

CH Saint-Joseph et Saint-Luc Service de Gastro-Entérologie

Lyon Cedez 07, , France

Site Status

Centre Hospitalier Privé Clairval Service de Cancérologie

Marseille, , France

Site Status

Hôpital Nord Service d'Oncologie Multidisciplinaires et Innovations Thérapeutiques

Marseille, , France

Site Status

Clinique Claude Bernard Service de Chimiothérapie

Metz, , France

Site Status

Clinique Claude Bernard Service Chimiothérapie

Metz, , France

Site Status

Centre Hospitalier Layne Service d'Oncologie

Mont-de-Marsan, , France

Site Status

Centre Hospitalier de Belfort-Montbéliard Site du Mittan-Oncologie et radiothérapie

Montbéliard, , France

Site Status

Clinique Clementville Service d'Oncologie

Montpellier, , France

Site Status

CHU Montpellier - Hôpital Arnaud de Villeneuve Service de Cancérologie

Montpellier, , France

Site Status

Centre Hospitalier Emile Muller

Mulhouse, , France

Site Status

CH de Mulhouse - Hôpital Emile Muller Hôpital de Jour - Oncologie

Mulhouse, , France

Site Status

Polyclinique de Gentilly Service Oncologie Médicale

Nancy, , France

Site Status

CHU - Hôpital Hôtel Dieu Unité de Gastroentérologie

Nantes, , France

Site Status

CHU de Nantes - Hôpital Laënnec Service d'Oncologie Médicale

Nantes, , France

Site Status

Centre Hospitalier de Narbonne Oncologie / Hématologie

Narbonne, , France

Site Status

Hôpital Américain

Neuilly-sur-Seine, , France

Site Status

Institut Mutualiste Montsouris Service Oncologie Médicale

Paris, , France

Site Status

Clinique Alleray Labrouste Service d'Oncologie Médicale

Paris, , France

Site Status

Hôpital Européen Georges Pompidou Service d'Oncologie Médicale

Paris, , France

Site Status

Hôpital Européen Georges Pompidou Service Oncologie Médicale - 4e étage (ascenseur B)

Paris, , France

Site Status

Hôpital Bichat Claude Bernard Service Hépato-Gastroentérologie et Cancérologie Digestive

Paris, , France

Site Status

Hôpital Tenon Service d'oncologie médicale

Paris, , France

Site Status

Centre Hospitalier Service d'Oncologie

Perpignan, , France

Site Status

Centre Hospitalier Service de Pneumologie

Perpignan, , France

Site Status

Centre Hospitalier Annecy Genevois Service Pneumologie

Pringy, , France

Site Status

Centre Hospitalier de la region d'Annecy Pole Medecine

Pringy, , France

Site Status

CH de Cornouaille Service d'Oncologie Médicale

Quimper, , France

Site Status

Institut Jean Godinot

Reims, , France

Site Status

Clinique de l'Europe Unité d'Oncologie

Rouen, , France

Site Status

Hôpital de Saint-Avold Service Oncologie II

Saint-Avold, , France

Site Status

Clinique François 1er

Saint-Dizier, , France

Site Status

Centre Hospitalier Privé Saint Grégoire Service d'Oncologie - Radiothérapie

Saint-Grégoire, , France

Site Status

Centre Hospitalier Privé Saint-Grégoire Service d'Oncologie - Radiothérapie

Saint-Grégoire, , France

Site Status

Centre Clinical Service d'Oncologie-Radiothérapie

Soyaux, , France

Site Status

Centre de Radiothérapie SCP Strasbourg Oncologie Libérale

Strasbourg, , France

Site Status

Hôpital Bel Air Service Pneumologie

Thionville, , France

Site Status

Hôpital de Thionville Service Oncologie Médicale

Thionville, , France

Site Status

Hôpital Rangueil Service d'Oncologie Médicale Digestive et Gynécologique

Toulouse, , France

Site Status

Clinique Pasteur

Toulouse, , France

Site Status

Hôpital Bretonneau Service d'Oncologie Médicale

Tours, , France

Site Status

Countries

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France

Other Identifiers

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C1121007

Identifier Type: OTHER

Identifier Source: secondary_id

VISTA

Identifier Type: -

Identifier Source: org_study_id

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