ITMO Santé Publique
ITMO Santé Publique
Date de modification : 22/07/2015 | Version : 3 | ID : 2907
| Général | |
| Identification | |
| Nom détaillé | Field Study of innovative therapies in oncology: bevacizumab (Avastin®), an anti-angiogenic agent |
| Sigle ou acronyme | ETNA |
| Numéro d'enregistrement (ID-RCB ou EUDRACT, CNIL, CPP, etc.) | CCTI-RS 06 270, CNIL 906234 |
| Thématiques générales | |
| Domaine médical |
Cancer research |
| Déterminants de santé |
Iatrogenic |
| Mots-clés | Metastatic colorectal cancer, first-line, conditions of use, pharmacoepidemiology, Department of Pharmacology, bevacizumab, Avastin®, tolerance, survival, cohort, 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@pharmaco.u-bordeaux2.fr | |
| Laboratoire | Service de Pharmacologie, CIC-P 0005-INSERM U657- Université Bordeaux Segalen |
| Organisme | Université Bordeaux |
| Collaborations | |
| Financements | |
| Financements |
Mixed |
| Précisions | National Hospital Clinical Research Program (PHRC) 2005 and additional financial support from Roche SAS (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 |
An administrative base or a register |
| 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 | Patients treated for the first time by bevacizumab between 1 January 2006 and 31 December 2007 were identified from pharmacy dispensation records of the participating centres. This retrospective identification of patients through pharmacies strengthens the non-interventional aspect, as it does not affect the prescription of the drug. Prescribers in the study were to then inform patients about the collection of their personal data. Patients opposing the collection of data could express this via the physician or by by an instruction included in their medical records, and such patients were not included. |
| Objectif de la base de données | |
| Objectif principal | The main objectives of the study were to describe the population of patients with metastatic colorectal cancer and treated in real-life with first-line bevacizumab, describe the conditions of use of this drug, evaluate the safety of treatments and effectiveness in terms of response and overall and progression free survival at 12 and 24 months follow up. |
| Critères d'inclusion | Patient with metastatic colorectal cancer who initiated bevacizumab in first-line palliative treatment regardless of the associated cancer treatment between 1 January 2006 and 31 December 2007 (whether or not the treatment is continued); Interval between adjuvant chemotherapy for primary cancer and the initiation of bevacizumab ≥6 months; Absence of chemotherapy for metastases before initiation of bevacizumab; Patient had not previously treated with bevacizumab, including during a clinical trial or Temporary Authorisation of Use; Patient with a prescribing physician or their head of department who agreed to participate in the study; Patient not participating in a clinical trial (Huriet-Sérusclat), unless it has a standard treatment (control arm) in an open-label Phase III study (bevacizumab known); Patient not objecting to the 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 | 2007 |
| Année du dernier recueil | 2011 |
| Taille de la base de données | |
| Taille de la base de données (en nombre d'individus) |
< 500 individuals |
| Détail du nombre d'individus | 411 |
| 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 |
Hospitalization Medicines consumption |
| Modalités | |
| Mode de recueil des données | All medical data required for the study is collected on paper case report forms from medical records by CRAs trained for this study. |
| Suivi des participants |
Yes |
| Détail du suivi | The treatment modalities for eligible patients are collected over 24 months follow-up from the date of the first bevacizumab administration. Vital status is collected at 36 months. Patient characteristics before initiation of treatment and follow-up data are collected from information 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/?term=%28Fourrier-Reglat+A[author]+OR+Moore+N[author]%29+AND+Etna |
| Description | List of publications in Pubmed |
| Accès | |
| Charte d'accès aux données (convention de mise à disposition, format de données et délais de mise à disposition) | Confidential study reports were submitted to the pharmaceutical company and the Bordeaux University Hospital (study sponsor). Scientific communications (posters, articles, ...) are validated by the study Steering Committee. Ownership of study data was the subject of an agreement between the University of Bordeaux Segalen, the Bordeaux University Hospital 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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