ITMO Santé Publique
ITMO Santé Publique
Date de modification : 01/01/2020 | Version : 1 | ID : 155
| Général | |
| Identification | |
| Nom détaillé | Female patients with breast cancer treated with lapatinib in the context of an expanded access program (ATU): description of the care trajectory and clinical course |
| Sigle ou acronyme | LAPS |
| Numéro d'enregistrement (ID-RCB ou EUDRACT, CNIL, CPP, etc.) | CNIL : 1213267 |
| Thématiques générales | |
| Domaine médical |
Cancer research |
| Autres, précisions | Breast cancer |
| Mots-clés | HER2+, Tyverb |
| Responsable(s) scientifique(s) | |
| Nom du responsable | Leclerc-Zwirn |
| Prénom | Christel |
| Téléphone | +33 (0)1 39 17 86 96 |
| christel.c.leclerc-zwirn@gsk.com | |
| Laboratoire | Laboratoire GSK |
| Collaborations | |
| Financements | |
| Financements |
Private |
| Précisions | GSK laboratory |
| Gouvernance de la base de données | |
| Organisation(s) responsable(s) ou promoteur | Laboratoire GSK |
| Statut de l’organisation |
Secteur Privé |
| Contact(s) supplémentaire(s) | |
| Caractéristiques | |
| Type de base de données | |
| Type de base de données |
Study databases |
| Base de données issues d'enquêtes, précisions |
Not-repeated cross-sectional studies (except case control studies) |
| Origine du recrutement des participants |
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 |
One hundred centers have filed at least one TUA request as of July 31, 2007 (about 3 months before the initiation of the study): about thirty of these are centers of substantial size (at least 5 patients, 10 patients on the average), the other 70 are small centers (less than 5 patients, 4 patients on the average). The study will be proposed to 80% of the centers in each stratum (center size). The random drawing will make it possible, as such, to retain 56 small centers and 25 large centers. Based on an estimated response rate of 70%, 40 small centers and 18 large centers will in the end participate in the study: Random drawing and number of patients expected: Based on the eligibility criteria retained, an additional CRF will have to be completed for all of the patients of a center. No random drawing will be carried out at this level. Approximately 570 patients received a treatment via lapatinib over the period of the study retained. Based on participation of 58 of the 81 centers that had requested a TUA, to which this study will be proposed, 330 completed dossiers can be expected. |
| Objectif de la base de données | |
| Objectif principal | Describe the care pathways of patients with breast cancer who have received and/or are receiving treatment with lapatinib under Temporary Use Authorization (TUA) |
| Critères d'inclusion | Patient who has received lapatinib for the treatment of breast cancer within the framework of a TUA between January 1, 2007 and 3 months prior to the beginning of the study |
| 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 |
Woman |
| Champ géographique |
National |
| Détail du champ géographique | France |
| Collecte | |
| Dates | |
| Année du premier recueil | 2008 |
| Année du dernier recueil | 2010 |
| Taille de la base de données | |
| Taille de la base de données (en nombre d'individus) |
< 500 individuals |
| Détail du nombre d'individus | 198 |
| Données | |
| Activité de la base |
Data collection completed |
| Type de données recueillies |
Clinical data |
| Données cliniques, précisions |
Direct physical measures Medical registration |
| 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 Medical/paramedical consultation Medicines consumption |
| Modalités | |
| Mode de recueil des données | The investigating centers (prescribing doctor) that have accepted to carry out the study will receive a CRF for all of their patients eligible for the study: patient number, sex, age and treatment start date will be pre-completed in order to identify the patients. Prescribing doctors will complete the CRF using the medical doctor, based on the information available, and will return it to the logistics center |
| Suivi des participants |
No |
| Appariement avec des sources administratives |
No |
| Valorisation et accès | |
| Valorisation et accès | |
| Accès | |
| Charte d'accès aux données (convention de mise à disposition, format de données et délais de mise à disposition) |
Abstract (ISPOR 2009) Publication in progress |
| Accès aux données agrégées |
Access on specific project only |
| Accès aux données individuelles |
Access on specific project only |
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