ITMO Santé Publique
ITMO Santé Publique
Date de modification : 25/10/2016 | Version : 1 | ID : 73329
| Général | |
| Identification | |
| Nom détaillé | Observational, retrospective study exploring RAS mutation tests practices in patients with metastatic colorectal cancer in 2014 |
| Sigle ou acronyme | Flash-RAS |
| Numéro d'enregistrement (ID-RCB ou EUDRACT, CNIL, CPP, etc.) | CNIL n°1748157 |
| Thématiques générales | |
| Domaine médical |
Anatomy - Cytology Biology Cancer research |
| Pathologie, précisions | Colorectal cancer |
| Déterminants de santé |
Healthcare system and access to health care services |
| Mots-clés | RAS mutation tests, Colorectal cancer |
| Responsable(s) scientifique(s) | |
| Nom du responsable | ARTRU |
| Prénom | Pascal, MD |
| Laboratoire | Gastroenterology, Hepatology and Gastrointestinal Oncology Department, Hôpital Jean Mermoz, lyon, France |
| Nom du responsable | DUCREUX |
| Prénom | Michel, Prof |
| Laboratoire | Gastroenterology Unit, Gustave Roussy, Villejuif, France |
| Nom du responsable | LAURENT-PUIG |
| Prénom | Pierre, Prof |
| Laboratoire | Biochemistry Department, HEGP, Paris, France |
| Nom du responsable | LIEVRE |
| Prénom | Astrid, MD |
| Laboratoire | Gastroenterology Department, Pontchaillou University hospital, Rennes, France |
| Nom du responsable | MERLIN |
| Prénom | Jean Louis, Prof |
| Laboratoire | Biopathology department, Institut de Cancérologie de Lorraine, Nancy, France |
| Nom du responsable | SABOURIN |
| Prénom | Jean-Christophe, Prof |
| Laboratoire | Pathology department, CHU Ch.Nicolle, Rouen, France |
| Collaborations | |
| Participation à des projets, des réseaux, des consortiums |
No |
| Financements | |
| Financements |
Private |
| Précisions | Merck |
| Gouvernance de la base de données | |
| Organisation(s) responsable(s) ou promoteur | Merck |
| Statut de l’organisation |
Secteur Privé |
| Existence de comités scientifique ou de pilotage |
Yes |
| Labellisations et évaluations de la base de données | Scientific committee |
| Contact(s) supplémentaire(s) | |
| Caractéristiques | |
| Type de base de données | |
| Type de base de données |
Study databases |
| Origine du recrutement des participants |
A selection of health care professionals A selection of health institutions and services |
| Critère de sélection des participants |
Another treatment or procedure |
| 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 | A list of hospital physicians (oncologists and gastroenterologists) treating patients with metastatic colorectal cancer in France, issued from the program of Medicalisation of data system (PMSI) and/or having taken part in the Flash-KRAS Study in 2011, were invited to participate in the study by letter or by telephone. |
| Objectif de la base de données | |
| Objectif principal |
To assess the RAS (KRAS and NRAS exons 2,3 and 4) mutation screening test request and realisation rates in patients with a recent diagnosis of metastatic colorectal cancer.
Secondary objectives: - To describe changes in the KRAS (exon 2) mutation test request rate between 2011 and 2014; - To describe the reasons for requesting/not requesting and performing/not performing these tests as a function of physician and patient profiles - To describe and to analyse the impact of KRAS (exons 2,3 and 4) and NRAS (exons 2.3 and 4) results, the anatomopathology department availability to provide the tests, and the BRAF result, on therapeutic decision-making or changes in ongoing treatment; - To describe and analyse clinical characteristics of patients and treatments planned and received as first-line therapy of metastatic disease; - To describe the laboratory test method, the type of mutation request (if available) and the method and route by which the result was communicated to the physicians (result report); - To describe and to analyse the time to receipt the KRAS and NRAS results, the process (who ordered the test and when) and the therapeutic approach chosen during this period |
| Critères d'inclusion |
To obtain the best possible representativeness while limiting bias, the physician had to screen consecutive patients followed for metastatic colorectal cancer and who had to satisfy the following criteria:
- patients 18 years of age or older, - patients with metastatic colorectal cancer histologically-confirmed after march 2014 (date the NRAS tests become available in French centers), - patients seen by the physician between June 15th , 2014 and September 30th, 2014 who have already started first-line treatment, during that time interval, for mCRC - patients in whom first-line therapy of metastatic disease had been already initiated between March 1st, 2014 and June 30th, 2014 - patients seen in a routine visit during the official 15-week screening period 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 |
Male Woman |
| Champ géographique |
National |
| Détail du champ géographique | France |
| Collecte | |
| Dates | |
| Année du premier recueil | 15/06/2014 |
| Année du dernier recueil | 30/09/2014 |
| Taille de la base de données | |
| Taille de la base de données (en nombre d'individus) |
< 500 individuals |
| Détail du nombre d'individus | N= 375 patients, included by 104 physicians |
| Données | |
| Activité de la base |
Data collection completed |
| Type de données recueillies |
Clinical data Declarative data Biological data |
| Données cliniques, précisions |
Medical registration |
| Détail des données cliniques recueillies | History of primary colorectal cancer; first-line therapy of metastatic disease; request for KRAS marker genotyping; impact of result on therapeutic management |
| Données déclaratives, précisions |
Paper self-questionnaire |
| Détail des données déclaratives recueillies | Physician's demographic characteristics; data related to his/her practice; size of community of practice; date the NRAS test became available in the pathology/department center; demographic data on patients |
| Données biologiques, précisions | Waiting period for test result; genotyping test report |
| Existence d’une biothèque |
No |
| Paramètres de santé étudiés |
Health care consumption and services |
| Modalités | |
| Mode de recueil des données | Data collected were obtained from the medical notes of patients seen at a visit during the study period (data already recorded), restrospectively with a paper questionnaire and the copy of the molecular biology report from which all reference to the patient by name had been removed to be anonymous |
| Suivi des participants |
No |
| Appariement avec des sources administratives |
No |
| Valorisation et accès | |
| Valorisation et accès | |
| Lien vers le document | FLASH RAS poster Carrefour patho 2015 VF.pdf |
| Description | Carrefour pathologie, Novembre 2015 |
| Lien vers le document | FLASH RAS poster ISPOR 2015 VF.pdf |
| Description | ISPOR, Novembre 2015 |
| Lien vers le document | poster_FlashRAS_120x80cm_HD_stdc - JFHOD 2015- VF.pdf |
| Description | JFHOD 2015 |
| Lien vers le document | FLASH RAS communication orale PEP7 VF.pptx |
| Description | Communication orale, 7° colloque PEP 2015 |
| Lien vers le document | Poster ESMO.pdf |
| Description | ESMO, Septembre 2015 |
| Accès | |
| Existence d’un document qui répertorie les variables et les modalités de codage |
No |
| Charte d'accès aux données (convention de mise à disposition, format de données et délais de mise à disposition) |
Methods of access are currently being defined.
Contact: juliette.longin@merckgroup.com |
| Accès aux données agrégées |
Access on specific project only |
| Accès aux données individuelles |
No access |
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