Etude : PROACTIF / BTG-007996-01



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Acronyme
Nom
Traitement
Type d'étude
MÀJ
Présentation de l'étude
Acronyme : PROACTIF

Nom : BTG-007996-01

Traitement :

Type d'étude : Qualité de vie / Observationnelle

Dernière MÀJ : 28/11/2019
Titre
Spécialité(s)
CIM10 - Localisation(s)
Informations principales
Titre : Non-Interventional Registry Study to Evaluate the Effectiveness of TheraSphere® in the Treatment of Hepatocellular Carcinoma (HCC)

Spécialité : Organes digestifs
Localisation : C22 - Tumeur maligne du foie et des voies biliaires intrahépatiques
Schéma
Phase
Stade
Ligne(s)
Informations complémentaires
Schéma : The purpose of this registry study is to gather effectiveness, QoL, safety and procedural information on TheraSphere® for the treatment of participants with HCC in real world clinical practice settings in France.
TheraSphere® is a radioembolic therapeutic device used in the treatment of liver cancers. The goal of the registry study is to collect prospectively: participant description, treatment goal, treatment description, treatment results, safety, quality of life and survival data to ultimately demonstrate that TheraSphere® treatment meets the claims that led to the reimbursement in France. The registry study is also an opportunity to improve the proper use of the device by team training especially for the personalized dosimetry treatment approach.

Clinical data will be collected and held in a secured, validated system and can be downloaded by BTG Data Management on an ongoing basis. Data verification will be performed by BTG Data Management and data validation checks will be created by the validated data system (with the BTG team performing User Acceptance Testing on them before they go live). Adverse Events and concomitant diseases will be coded according to the version of Medical Dictionary for Regulatory Activities (MedDRA) agreed with Biocompatibles UK Ltd. Concomitant medications will be coded using the version of the World Health Organisation (WHO) Drug dictionary agreed with the validated data system.

Phase : NA

Stade : NA

NA
Informations libres de droit
Critères d'inclusion
Critères de non-inclusion
Informations libres de droit
Critères d'inclusion et de non-inclusion
Critères d'inclusion : Participant has received a reimbursed dose of TheraSphere®
Participant does not oppose to the collection of his/her medical personal data

Critères de non-inclusion : Participant has opposed to data collection
Participant has not received a reimbursed dose of TheraSphere® (free of charge dose)
NCT
Promoteur
Coordonnateur
Informations relatives au promoteur
NCT :
NCT04069468
Promoteur :
Biocompatibles UK Ltd
Type de sponsor : Industriel
00000 HORS FRANCE

Coordonnateur :
Centre investigateur
Investigateur
TEC / ARC / IDE
État
MÀJ
Informations relatives aux investigateurs
Centre investigateur :
CHU de Rouen - 1 Rue de Germont - 76000 ROUEN

Investigateur :
David SEFRIOUI

TEC / ARC / IDE :
Patricia FOSSE
patricia.fosse@
chu-rouen.fr
02 32 88 86 10 poste 64 462

Ouverture de l'essai : OUVERT

MAJ : 28/11/2019