ITMO Santé Publique
ITMO Santé Publique
Date de modification : 05/09/2017 | Version : 3 | ID : 3195
| Général | |
| Identification | |
| Nom détaillé | Velcade: study of real-life use |
| Sigle ou acronyme | VESUVE (beta) |
| Numéro d'enregistrement (ID-RCB ou EUDRACT, CNIL, CPP, etc.) | CCTI-RS 05 375, CNIL 1133894 |
| Thématiques générales | |
| Domaine médical |
Cancer research Hematology |
| Mots-clés | Multiple myeloma, Velcade®, Bortezomib, survival, conditions of use, pharmacoepidemiology, cohort, Department of Pharmacology, Bordeaux |
| Responsable(s) scientifique(s) | |
| Nom du responsable | Fourrier-Reglat |
| Prénom | Annie |
| Adresse | Bât du Tondu - Case 41 - 146, Rue Léo Saignat - 33076 BORDEAUX Cedex |
| Téléphone | + 33(0)5 57 57 46 75 |
| Annie.fourrier@pharmaco.u-bordeaux2.fr | |
| Laboratoire | Service de Pharmacologie, CIC-P 0005-INSERM U657- Université Bordeaux Segalen |
| Organisme | Université Bordeaux |
| Nom du responsable | Moore |
| Prénom | Nicholas |
| Adresse | Bât du Tondu - Case 41 - 146, Rue Léo Saignat - 33076 BORDEAUX Cedex |
| Téléphone | + 33 (0)5 57 57 46 75 |
| nicholas.moore@u-bordeaux.fr | |
| Laboratoire | Service de Pharmacologie, CIC-P 0005-INSERM U657- Université Bordeaux Segalen |
| Organisme | Université Bordeaux |
| Collaborations | |
| Financements | |
| Financements |
Mixed |
| Précisions | Laboratoire Janssen-Cilag France (soutien inconditionnel) - Janssen-Cilag France (unconditional support) |
| Gouvernance de la base de données | |
| Organisation(s) responsable(s) ou promoteur | Service de Pharmacologie, CIC-P 0005-INSERM U657- Université Bordeaux Segalen |
| Statut de l’organisation |
Secteur Public |
| Contact(s) supplémentaire(s) | |
| Caractéristiques | |
| Type de base de données | |
| Type de base de données |
Study databases |
| Base de données issues d'enquêtes, précisions |
Longitudinal study (except cohorts) |
| Origine du recrutement des participants |
A selection of health care professionals A selection of health institutions and services |
| Critère de sélection des participants |
Medication(s) taken |
| Le recrutement dans la base de données s'effectue dans le cadre d'une étude interventionnelle |
No |
| Informations complémentaires concernant la constitution de l'échantillon | All hospital pharmacies that purchased bortezomib at the time of study implementation were contacted. Pharmacists of participating centres have, from nominative dispensation registers, identified patients who received a first prescription of bortezomib during the study period. The prescribing physicians were contacted and asked to participate in the study. Participating physcians informed patients of the study and gave access to medical records to the CRAs in charge of the data collection. |
| Objectif de la base de données | |
| Objectif principal | The objectives are to evaluate the response and survival of patients treated by Velcade®, to describe the population of patients initiating treatment with Velcade® (socio-demographic data, previous treatments, indication), and describe the conditions of use Velcade® (dose, number and frequency of treatment cycles) |
| Critères d'inclusion | Patients initiating Bortezomib treatment between 1 May 2004 and April 30 2006 (whether or not treatment is continued); Patient unexposed to bortezomib, including during a clinical trial or temporary use authorization; Patient followed by a hospital physician having agreed to participate in the study; Patient not participating in a clinical trial; Patient not objecting to data collection |
| Type de population | |
| Age |
Adulthood (19 to 24 years) Adulthood (25 to 44 years) Adulthood (45 to 64 years) Elderly (65 to 79 years) Great age (80 years and more) |
| Population concernée |
Sick population |
| Sexe |
Male Woman |
| Champ géographique |
National |
| Détail du champ géographique | Hospital pharmacists and physicians in metropolitan France |
| Collecte | |
| Dates | |
| Année du premier recueil | 2004 |
| Année du dernier recueil | 2006 |
| Taille de la base de données | |
| Taille de la base de données (en nombre d'individus) |
[500-1000[ individuals |
| Détail du nombre d'individus | 1310 patients identified by hospital pharmacists, including 924 patients for whom their physician agreed to participate in the study, and 793 patients were eligible for follow up. |
| Données | |
| Activité de la base |
Data collection completed |
| Type de données recueillies |
Clinical data |
| Données cliniques, précisions |
Direct physical measures |
| Existence d’une biothèque |
No |
| Paramètres de santé étudiés |
Health event/morbidity Health event/mortality Health care consumption and services |
| Consommation de soins, précisions |
Medicines consumption |
| Modalités | |
| Mode de recueil des données | CRAs have collected data on site using a standardized electronic case report forms (e-CRF). The indication for treatment with bortezomib was collected for all patients, but only those treated for multiple myeloma were followed. |
| Suivi des participants |
Yes |
| Détail du suivi | Patients treated for multiple myeloma are followed over three years (from the date of first administration of Velcade®) using data available in medical records. |
| Appariement avec des sources administratives |
No |
| Valorisation et accès | |
| Valorisation et accès | |
| Lien vers le document | http://www.ncbi.nlm.nih.gov/pubmed/23808815 |
| Lien vers le document | http://www.asco.org/ASCOv2/Meetings/Abstracts?&vmview |
| Accès | |
| Charte d'accès aux données (convention de mise à disposition, format de données et délais de mise à disposition) | A confidential study report was submitted to the pharmaceutical company and sent to health authorities after validation by the study Scientific Committee. Ownership of study data was the subject of an agreement between the University of Bordeaux Segalen and the pharmaceutical company. Terms for third-party access to the database are to be defined. |
| Accès aux données agrégées |
Access on specific project only |
| Accès aux données individuelles |
Access on specific project only |
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