{"doc_desc":{"title":"\u00c9tude observationnelle pharmaco-\u00e9pid\u00e9miologique sur le b\u00e9n\u00e9fice clinique de Neorecormon\u00ae chez les patients atteints de cancer et souffrant d'an\u00e9mie, en fonction de la r\u00e9ponse pr\u00e9coce au traitement","idno":"FRESH-PEF74132-fr","producers":[{"name":"Camille BACHOT","affiliation":"F. HOFFMANN-LA ROCHE AG"}]},"study_desc":{"title_statement":{"idno":"FRESH-PEF74132-fr","IDno":{"metadata_no":[{"agency":"PEF","code":"74132"},{"agency":"FReSH","code":"FRESH-PEF74132"},{"agency":"NCT","code":"NCT01168349"}]},"title":"\u00c9tude observationnelle pharmaco-\u00e9pid\u00e9miologique sur le b\u00e9n\u00e9fice clinique de Neorecormon\u00ae chez les patients atteints de cancer et souffrant d'an\u00e9mie, en fonction de la r\u00e9ponse pr\u00e9coce au traitement","alternate_title":"FAST"},"study_authorization":{"agency":[{"name":"Autre"}]},"authoring_entity":[],"oth_id":[{"name":""}],"production_statement":{"prod_place":"Portail Epid\u00e9miologie France (PEF)","producers":[{"name":"F. HOFFMANN-LA ROCHE AG","extlink":[{"title":"SIREN","uri":"775752140","role":"sponsor id"}],"role":"sponsor"}],"funding_agencies":[{"name":""}]},"distribution_statement":{"contact":[{"name":";Medical data center","lastname":"Medical data center","firstname":"","type":"contact","email":"data_sharing.france@roche.com","affiliationName":"F. HOFFMANN-LA ROCHE AG","contactPointLabo":"","extlink":[{"uri":"https:\/\/ror.org\/01mqmer16","role":"organisation id","title":"ROR"},{"uri":"775752140","role":"organisation id","title":"SIREN"}]}]},"study_info":{"keywords":[{"keyword":"\u00e9po\u00e9tine b\u00eata"}],"topics":[{"topic":"Oncologie","vocab":"health theme","extLink":[{"title":"ESV","uri":"http:\/\/data.europa.eu\/8mn\/euroscivoc\/5784b7f1-c7ce-49d9-9f38-aebcda0ff41d"},{"title":"MeSH","uri":"http:\/\/id.nlm.nih.gov\/mesh\/D008495"}]},{"topic":"Tumeurs","vocab":"cim-11","extLink":[{"uri":"http:\/\/id.who.int\/icd\/entity\/1630407678","title":"CIM-11"}]},{"topic":"D\u00e9terminants li\u00e9s au syst\u00e8me de sant\u00e9 : Consommation des soins","vocab":"health determinant"},{"topic":"D\u00e9terminants li\u00e9s au syst\u00e8me de sant\u00e9","vocab":"health determinant"}],"purpose":"Objectif principal : D\u00e9crire en conditions r\u00e9elles le b\u00e9n\u00e9fice clinique (c'est-\u00e0-dire la r\u00e9duction des transfusions, le maintien de l'\u00e9tat de sant\u00e9 g\u00e9n\u00e9ral et des activit\u00e9s professionnelles et sociales) de NeoRecormon\u00ae chez les patients an\u00e9miques atteints de cancer, en fonction de la r\u00e9ponse pr\u00e9coce au traitement. - La r\u00e9ponse pr\u00e9coce \u00e0 NeoRecormon\u00ae a \u00e9t\u00e9 d\u00e9finie comme une augmentation de la concentration d'h\u00e9moglobine d'au moins 1 g\/dl, 4 \u00e0 6 semaines apr\u00e8s le d\u00e9but du traitement. Objectifs secondaires : Dans la population totale et dans chaque sous-population de patients [type de pathologie (tumeur solide, h\u00e9mopathie maligne ou autogreffe), pathologie canc\u00e9reuse] : 1. d\u00e9crire les caract\u00e9ristiques des patients \u00e0 l'inclusion ; 2. d\u00e9crire l'utilisation de NeoRecormon\u00ae et la conformit\u00e9 aux directives actuelles [autorisation de mise sur le march\u00e9 (AMM), European Organisation for Research and Treatment of Cancer (EORTC)] ; 3. d\u00e9crire l'\u00e9volution du taux d'h\u00e9moglobine (Hb) ; 4. d\u00e9crire l'\u00e9volution du statut en fer et de la suppl\u00e9mentation en vitamines ; 5. d\u00e9crire les \u00e9v\u00e9nements ind\u00e9sirables (EI) et les EI graves (EI cibl\u00e9s et non cibl\u00e9s).","abstract":"","coll_dates":[{"start":"2010-01-01","end":"2010-12-31"}],"nation":[{"name":"France","abbreviation":"fr","extLink":{"vocab":"ISO","vocabURI":"fr"}}],"geog_coverage":"","analysis_unit":"Individus","universe":"{\n    \"level_sex_clusion_I\": [\n        {\n            \"value\": \"Masculin\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D008297\"\n            }\n        },\n        {\n            \"value\": \"F\u00e9minin\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D005260\"\n            }\n        }\n    ],\n    \"level_age_clusion_I\": [\n        {\n            \"value\": \"Adulte (19 \u00e0 24 ans)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D055815\"\n            }\n        },\n        {\n            \"value\": \"Adulte (25 \u00e0 44 ans)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D000328\"\n            }\n        },\n        {\n            \"value\": \"Adulte (45 \u00e0 64 ans)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D008875\"\n            }\n        },\n        {\n            \"value\": \"Personne \u00e2g\u00e9e (65 \u00e0 79 ans)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D000368\"\n            }\n        },\n        {\n            \"value\": \"Grand \u00e2ge (80 ans et plus)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D000369\"\n            }\n        }\n    ],\n    \"level_type_clusion_I\": \"Patients\",\n    \"level_type_clusion_other\": \"\",\n    \"clusion_I\": \"Crit\u00e8res d'inclusion : - Patient adulte (\u00e2g\u00e9 de >= 18 ans) ; - Patient recevant une chimioth\u00e9rapie my\u00e9losuppressive (avec ou sans radioth\u00e9rapie) pour une tumeur solide (sein, colorectal, poumon, ovaire), une tumeur h\u00e9matologique maligne (my\u00e9lome multiple, leuc\u00e9mie lympho\u00efde chronique, lymphome), ou une autogreffe pour une tumeur h\u00e9matologique maligne ; - Patient sans traitement par agents stimulant l'\u00e9rythropo\u00ef\u00e8se (ASE), ni transfusion de globules rouges dans les 4 semaines pr\u00e9c\u00e9dant l'inscription ; - Patient pour lequel le m\u00e9decin a d\u00e9cid\u00e9 d'initier le traitement par NeoRecormon\u00ae lors de la visite d'inclusion ; - Esp\u00e9rance de vie du patient ? 6 mois selon l'avis du m\u00e9decin ; - Patient acceptant et capable de remplir un questionnaire \u00e9crit en fran\u00e7ais sur ses activit\u00e9s professionnelles et sociales lors de 4 visites, - Patient ayant re\u00e7u une information orale et \u00e9crite sur l'\u00e9tude et ne s'\u00e9tant pas oppos\u00e9 au traitement de ses donn\u00e9es personnelles.  \",\n    \"clusion_E\": \"Aucun\"\n}","data_kind":"['Donn\u00e9es cliniques','Donn\u00e9es rapport\u00e9es par le participant de l'\u00e9tude','Donn\u00e9es biologiques']","quality_statement":{"standards":[{"name":"['CDISC']","committee":"","governance":""}],"other_quality_statement":"['Bonnes pratiques cliniques\/Bonnes Pratiques de Pharmacovigilance (GCP\/GVP)']"}},"study_development":{"development_activity":[{"activity_type":"primary evaluation","activity_description":"Consommation de soins\/services de sant\u00e9"}]},"method":{"data_collection":{"time_method":"","frequency":"","sampling_procedure":"['{\"concept\":{\"vocabURI\":\"Other\",\"vocab\":\"CESSDA\"},\"value\":\"Autre\"}']","sample_frame":{"frame_unit":{"unit_type":"['Via des structures (services ou \u00e9tablissements de sant\u00e9, \u00e9coles, entreprises\u2026)']"}},"coll_mode":["{\"concept\":{\"vocabURI\":\"Transcription\",\"vocab\":\"CESSDA\"},\"value\":\"Transcription et saisie d\u2019informations dans un enregistrement structur\u00e9\"}"],"research_instrument":"Acc\u00e8s restreint sur projet sp\u00e9cifique","sources":[],"target_sample_size":"[1000-10000[ individus","response_rate":"1057"},"method_notes":"Etude observationnelle","study_class":"Inconnu","notes":[{"subject":"research type","values":["Etude observationnelle"]},{"subject":"observational study method","values":["Cohorte"]}]},"data_access":{"dataset_availability":{"access_place":"","complete":"","status":"{\"value\":\"Acc\u00e8s r\u00e9serv\u00e9\",\"extLink\":[{\"title\":\"COAR\",\"uri\":\"http:\/\/purl.org\/coar\/access_right\/c_16ec\"}]}"},"dataset_use":{"restrictions":"","conditions":"","conf_dec":[{"txt":""}],"spec_perm":[{"txt":"","required":""}],"contact":[{"name":""}],"deposit_req":"","cit_req":""},"notes":""}},"additional":{"IsImport":true,"versionLang":"fr","originLang":"fr","autoTranslation":false,"status":"imported","creationDate":"23-06-2022","lastUpdatedAuto":null,"lastUpdatedManual":"07-07-2025","isContributorPI":false,"contributorName":"Camille BACHOT","contributorAffiliation":"F. HOFFMANN-LA ROCHE AG","addTeamMember":"","obtainedAuthorization":{"otherAuthorizingAgency":[""]},"relatedDocument":[],"regulatoryRequirements":{"conformityDeclaration":""},"fundingAgent":{"fundingAgentType":[],"otherFundingAgentType":[]},"sponsor":{"sponsorType":["Industrie"],"otherSponsorType":[""]},"governance":{"committee":true},"collaborations":{"networkConsortium":""},"theme":{"complementaryInformation":"","RareDiseases":""},"activeFollowUp":{"isActiveFollowUp":true,"followUpModeOther":""},"interventionalStudy":{"researchPurpose":[],"trialPhase":[],"interventionalStudyModel":"","isClinicalTrial":"","otherResearchPurpose":""},"isInclusionGroups":"","allocation":{"allocationMode":"","allocationUnit":""},"masking":{"maskingType":"","blindedMaskingDetails":[]},"arms":[],"intervention":[],"inclusionGroups":[],"collectionProcess":{"collectionModeDetails":"CRF papier","collectionModeOther":""},"dataCollection":{"inclusionStrategyOther":"","samplingModeOther":"","recruitmentSourceOther":"","otherDocumentation":""},"dataCollectionIntegration":{"isDataIntegration":false},"geographicalCoverage":{"geoDetail":""},"dataTypes":{"clinicalDataDetails":"Certificat attestant que le patient a \u00e9t\u00e9 inform\u00e9 de l'\u00e9tude - Crit\u00e8res d'\u00e9ligibilit\u00e9 - Activit\u00e9 professionnelle actuelle du patient - Donn\u00e9es d\u00e9mographiques - Histoire de la maladie - Traitement antitumoral - Traitements concomitants - \u00c9tat de performance de Karnofsky - Biochimie sanguine (h\u00e9moglobine Hb, ferritine, azote ur\u00e9ique sanguin, r\u00e9ticulocytes, fer s\u00e9rique, prot\u00e9ine C-r\u00e9active, albumine, saturation en transferrine) - \u00c9valuation de la prise en charge de l'an\u00e9mie - Traitements anticanc\u00e9reux - Transfusion sanguine - \u00c9v\u00e9nements ind\u00e9sirables - Cong\u00e9s de maladie et nombre de jours d'arr\u00eat de travail pendant l'\u00e9tude. R\u00e9sultats rapport\u00e9s par les patients (RRPs) : Signes physiques de l'an\u00e9mie - Questionnaire sur la productivit\u00e9 au travail et la perte d'activit\u00e9 : Sant\u00e9 g\u00e9n\u00e9rale V2.0.","biologicalDataDetails":"","isDataInBiobank":false,"biobankContent":[],"biobankContentOther":"","dataTypeOther":""},"variableDictionnary":{"variableDictionnaryAvailable":"","variableDictionnaryLink":""},"dataQuality":{"otherDocumentation":""},"mockSample":{"mockSampleAvailable":"","mockSampleLocation":""},"thirdPartySource":{"otherSourceType":[]},"isHealthTheme":true,"fileDscr":{"fileTxt":{"fileCitation":{"titlStmt":{"IDno":[]}}}}},"schematype":"survey"}