{"study_desc":{"title_statement":{"idno":"FRESH-PEF74132-en","IDno":{"metadata_no":[{"agency":"PEF","code":"74132"},{"agency":"FReSH","code":"FRESH-PEF74132"},{"agency":"NCT","code":"NCT01168349"}]},"title":"Pharmaco-epidemiological observational study of the clinical beneft of Neorecormon\u00ae in cancer patients with anaemia, according to early response to treatment","alternate_title":"FAST"},"study_authorization":{"agency":[{"name":"Other"}]},"authoring_entity":[],"oth_id":[{"name":""}],"production_statement":{"prod_place":"Epidemiology France Portal (PEF)","producers":[{"name":"F. HOFFMANN-LA ROCHE AG","extlink":[{"title":"SIREN","uri":"775752140","role":"sponsor id"},{"title":"ROR","uri":"https:\/\/ror.org\/01mqmer16","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":"Epoetin beta"}],"topics":[{"topic":"Oncology","vocab":"health theme","extLink":[{"title":"ESV","uri":"http:\/\/data.europa.eu\/8mn\/euroscivoc\/5784b7f1-c7ce-49d9-9f38-aebcda0ff41d"},{"title":"MeSH","uri":"D008495"}]},{"topic":"Neoplasms","vocab":"cim-11","extLink":[{"uri":"http:\/\/id.who.int\/icd\/entity\/1630407678","title":"CIM-11"}]},{"topic":"Healthcare system determinants: Use of care","vocab":"health determinant"},{"topic":"Healthcare system determinants","vocab":"health determinant"}],"purpose":"Primary objective: To describe in real-life conditions the clinical benefit (i.e. transfusion sparing, maintenance of general health status, and professional and social activities) of NeoRecormon\u00ae in anaemic cancer patients, according to early response to treatment. - Early response to NeoRecormon\u00ae was defined as an increase of hemoglobin concentration of at least 1 g\/dL, 4 to 6 weeks after treatment initiation. Secondary objectives: In the total population and in each sub-population of patients [type of pathology (solid tumor, hematological malignancy or autograft), cancer pathology]: 1. to describe patients\u2019 characteristics at inclusion; 2. to describe the use of NeoRecormon\u00ae and the compliance to current guidelines [Market Authorization (MA), EORTC]; 3. to describe the evolution of hemoglobin (Hb) level; 4. to describe the evolution of iron status and vitamin supplementation; 5. to describe Adverse Events (AEs) and serious AEs (targeted and non-targeted AEs).","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":"Individuals","universe":"{\"level_sex_clusion_I\":[{\"value\":\"Male\",\"concept\":{\"vocab\":\"MeSH\",\"vocabURI\":\"D008297\"}},{\"value\":\"Female\",\"concept\":{\"vocab\":\"MeSH\",\"vocabURI\":\"D005260\"}}],\"level_age_clusion_I\":[{\"value\":\"Young Adult (19 to 24 years)\",\"concept\":{\"vocab\":\"MeSH\",\"vocabURI\":\"D055815\"}},{\"value\":\"Adult (25 to 44 years)\",\"concept\":{\"vocab\":\"MeSH\",\"vocabURI\":\"D000328\"}},{\"value\":\"Middle Aged (45 to 64 years)\",\"concept\":{\"vocab\":\"MeSH\",\"vocabURI\":\"D008875\"}},{\"value\":\"Aged (65 to 79 years)\",\"concept\":{\"vocab\":\"MeSH\",\"vocabURI\":\"D000368\"}},{\"value\":\"Aged, 80 and over (80 years and more)\",\"concept\":{\"vocab\":\"MeSH\",\"vocabURI\":\"D000369\"}}],\"level_type_clusion_I\":\"Patients population\",\"level_type_clusion_other\":\"\",\"clusion_I\":\"Inclusion criteria: - Adult patient (aged >= 18 years); - Patient receiving myelosuppressive chemotherapy (with or without radiotherapy) for solid tumor (breast, colorectal, lung, ovary), hematological malignancy (multiple myeloma, CLL, lymphoma), or autograft for hematological malignancy; - Patient without erythropoiesis-stimulating agents (ESA) treatment, neither RBC transfusion within 4 weeks before enrollment; - Patient for whom the physician had decided to initiate NeoRecormon\u00ae treatment at the inclusion visit; - Patient\u2019s life expectancy ? 6 months according to the physician\u2019s opinion; - Patient accepting and able to complete a French written questionnaire about his\/her professional and social activities at 4 visits, - Patient who received about the study both oral and written information and who did not object to his\/her personal data being processed.  \",\"clusion_E\":\"None.\"}","data_kind":"['Clinical data','Biological data','Participant-reported health data']","quality_statement":{"standards":[{"name":"['CDISC']","committee":"","governance":""}],"other_quality_statement":"['GCP\/GVP']"}},"study_development":{"development_activity":[{"activity_type":"primary evaluation","activity_description":"Health care consumption and services"}]},"method":{"data_collection":{"time_method":"","frequency":"","sampling_procedure":"['{\"concept\":{\"vocabURI\":\"Other\",\"vocab\":\"CESSDA\"},\"value\":\"Other\"}']","sample_frame":{"frame_unit":{"unit_type":"['Through organizations (health services or institutions, schools, businesses, etc.)']"}},"coll_mode":["{\"concept\":{\"vocabURI\":\"Transcription\",\"vocab\":\"CESSDA\"},\"value\":\"Converting or copying information into a structured record\"}"],"research_instrument":"Access on specific project only","sources":[],"target_sample_size":"[1000-10000[ individuals","response_rate":"1057"},"method_notes":"Observational Study","study_class":"Unknown","notes":[{"subject":"research type","values":["Observational Study"]},{"subject":"observational study method","values":["Cohort study"]}]},"data_access":{"dataset_availability":{"access_place":"","complete":"","status":"{\"value\":\"Restricted access\",\"extLink\":[{\"title\":\"COAR\",\"uri\":\"http:\/\/purl.org\/coar\/access_right\/c_16ec\"}]}","notes":""},"dataset_use":{"restrictions":"","conditions":"","conf_dec":[{"txt":""}],"spec_perm":[{"txt":"","required":""}],"contact":[{"name":""}],"deposit_req":"","cit_req":""}}},"additional":{"versionLang":"en","originLang":"en","autoTranslation":false,"status":"Imported","creationDate":"23-06-2022","lastUpdatedManual":"07-07-2025","isContributorPI":"","contributorName":"Camille BACHOT","contributorAffiliation":"F. HOFFMANN-LA ROCHE AG","addTeamMember":"","obtainedAuthorization":{"otherAuthorizingAgency":[""]},"relatedDocument":[],"regulatoryRequirements":{"conformityDeclaration":""},"fundingAgent":{"fundingAgentType":[],"otherFundingAgentType":[]},"sponsor":{"sponsorType":["Industry"],"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":"paper CRF","collectionModeOther":""},"dataCollection":{"inclusionStrategyOther":"","samplingModeOther":"","recruitmentSourceOther":"","otherDocumentation":""},"dataCollectionIntegration":{"isDataIntegration":false},"geographicalCoverage":{"geoDetail":""},"dataTypes":{"clinicalDataDetails":"Certificate attesting that the patient had been informed about the study - Eligibility criteria - Patient\u2019s current professional activity - Demographics - History of the disease - Anti-tumour therapy - Concomitant medication - Karnofsky Performance Status - Blood biochemistry (Hb, ferritin, BUN, reticulocytes, serum iron, CRP albumin, TSAT) - Assessment of anaemia management - Cancer treatments - Blood transfusion - Adverse events - Sick leave and number of days off sick during the study. PROs: Physical signs of anaemia - Work Productivity and Activity Impairment Questionnaire: General Health 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"}