{"doc_desc":{"title":"Multicentric prospective cohort of children and adolescents malignant hemopathies","idno":"FRESH-PEF3269-en","producers":[{"name":"Fran\u00e7oise VION-DURY","affiliation":"UNIVERSITE D'AIX MARSEILLE"}]},"study_desc":{"title_statement":{"idno":"FRESH-PEF3269-en","IDno":{"metadata_no":[{"agency":"PEF","code":"3269"},{"agency":"FReSH","code":"FRESH-PEF3269"}]},"title":"Multicentric prospective cohort of children and adolescents malignant hemopathies","alternate_title":"LEA"},"study_authorization":{"agency":[]},"authoring_entity":[{"type":"investigator","name":"Pascal;AUQUIER","PILabo":"Assistance Publique-H\u00f4pitaux de Marseille (APHM), Aix-Marseille \/ EA 3279 - Sant\u00e9 Publique et Maladies Chroniques : Qualit\u00e9 de vie, Concepts, Usages et limites, D\u00e9terminants.","affiliationName":"ASSISTANCE PUBLIQUE HOPITAUX DE MARSEILLE (AP-HM)","extlink":[{"title":"","uri":"","role":"pi id"},{"title":"IdRef","uri":"059818085","role":"pi 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limites, D\u00e9terminants.","affiliationName":"ASSISTANCE PUBLIQUE HOPITAUX DE MARSEILLE (AP-HM)","extlink":[{"title":"","uri":"","role":"pi id"},{"title":"IdRef","uri":"059817941","role":"pi id"},{"title":"SIREN","uri":"261300081","role":"organisation id"},{"title":"RNSR","uri":"200014577Z","role":"labo id"}],"email":"marie-claude.simeoni@univ-amu.fr","isContact":"Yes"}],"oth_id":[{"name":""}],"production_statement":{"prod_place":"Epidemiology France Portal (PEF)","producers":[{"name":"ASSISTANCE PUBLIQUE HOPITAUX DE MARSEILLE (AP-HM)","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/002cp4060","role":"sponsor id"},{"title":"SIREN","uri":"261300081","role":"sponsor id"}],"role":"sponsor"}],"funding_agencies":[{"name":"AGENCE REGIONALE D'HOSPITALISATION (ARH)","extlink":[{"title":"SIREN","uri":"182500199"}]},{"name":"ASSISTANCE PUBLIQUE HOPITAUX DE MARSEILLE (AP-HM)","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/002cp4060"},{"title":"SIREN","uri":"261300081"}]},{"name":"AGENCE DE LA BIOMEDECINE","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/03tajza86"},{"title":"SIREN","uri":"180092587"}]},{"name":"AGENCE NATIONALE DE LA RECHERCHE (ANR)","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/00rbzpz17"},{"title":"SIREN","uri":"130002504"}]},{"name":"ASSOCIATION LAURETTE FUGAIN","extlink":[{"title":"SIREN","uri":"450599691"}]},{"name":"BRISTOL MYERS SQUIBB PHARMA FRANCE S.A","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/013b57229"},{"title":"SIREN","uri":"380059956"}]},{"name":"GUERIDUNCANCER","extlink":[{"title":"SIREN","uri":"808426266"}]},{"name":"INSTITUT NATIONAL DU CANCER (INCA)","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/03m8vkq32"},{"title":"SIREN","uri":"187512777"}]},{"name":"LIGUE NATIONALE CONTRE LE CANCER (LNCC)","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/00rkrv905"},{"title":"SIREN","uri":"775664717"}]},{"name":"MINISTERE DU TRAVAIL, DE LA SANTE, DES SOLIDARITES ET DES FAMILLES","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/01wp0c315"},{"title":"SIREN","uri":"130016546"}]},{"name":"MSD FRANCE","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/00kt5kp12"},{"title":"SIREN","uri":"417890589"}]},{"name":"REGION PACA","extlink":[{"title":"SIREN","uri":"231300021"}]},{"name":"","extlink":[]},{"name":"","extlink":[]}]},"distribution_statement":{"contact":[{"name":"Pascal;AUQUIER","email":"pascal.auquier@univ-amu.fr","type":"contact","affiliationName":"ASSISTANCE PUBLIQUE HOPITAUX DE MARSEILLE (AP-HM)","contactPointLabo":"","extlink":[{"uri":"https:\/\/ror.org\/002cp4060","role":"organisation id","title":"ROR"},{"uri":"261300081","role":"organisation id","title":"SIREN"}]},{"name":"G\u00e9rard;MICHEL","email":"gmichel@ap-hm.fr","type":"contact","affiliationName":"ASSISTANCE PUBLIQUE HOPITAUX DE MARSEILLE (AP-HM)","contactPointLabo":"","extlink":[{"uri":"https:\/\/ror.org\/002cp4060","role":"organisation id","title":"ROR"},{"uri":"261300081","role":"organisation id","title":"SIREN"}]},{"name":"Marie-Claude;SIMEONI","email":"marie-claude.simeoni@univ-amu.fr","type":"contact","affiliationName":"ASSISTANCE PUBLIQUE HOPITAUX DE MARSEILLE (AP-HM)","contactPointLabo":"","extlink":[{"uri":"https:\/\/ror.org\/002cp4060","role":"organisation id","title":"ROR"},{"uri":"261300081","role":"organisation id","title":"SIREN"}]}]},"study_info":{"keywords":[{"keyword":"Malignant hemopathies"},{"keyword":"Leukemia"},{"keyword":"Lymphoma"},{"keyword":"Sequelae of leukemia or its treatment"},{"keyword":"long term adverse side effects"},{"keyword":"children"},{"keyword":"adolescents"}],"topics":[{"topic":"Oncology","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":"Hematology","vocab":"health theme","extLink":[{"title":"ESV","uri":"http:\/\/data.europa.eu\/8mn\/euroscivoc\/9239f328-78c9-40a5-a0b9-8e66fd9b6245"},{"title":"MeSH","uri":"http:\/\/id.nlm.nih.gov\/mesh\/D006402"}]},{"topic":"Paediatrics","vocab":"health theme","extLink":[{"title":"ESV","uri":"http:\/\/data.europa.eu\/8mn\/euroscivoc\/bf8aaaac-ddee-41cd-bb8a-c5a63de3fcbd"},{"title":"MeSH","uri":"http:\/\/id.nlm.nih.gov\/mesh\/D010372"}]},{"topic":"Diseases of the blood or blood-forming organs","vocab":"cim-11","extLink":[{"uri":"http:\/\/id.who.int\/icd\/entity\/1766440644","title":"CIM-11"}]},{"topic":"Healthcare system determinants: Use of care","vocab":"health determinant"},{"topic":"Healthcare system determinants","vocab":"health determinant"}],"purpose":"General objective of the project : Describe the evolution at short and medium term of a cohort of patient treated for malignant hemopathy during their childhood, concerning: . quality of life in patient and its relatives . socio-economic insertion . health condition . relation to the health care system Study the determinants (medical, socio-economic, behavioral or environmental) of the evolution (health condition and quality of life) at medium and long term of a cohort of patients treated for malignant hemopathy during their childhood. Study predictive factors of the occurrence of long term sequelae of height and weight growth, puberty, fertility, thyroid function, visual function, cardiac function, viral contamination, pulmonary function, bone metabolism, iron metabolism, metabolic syndrome, other sequelae. Explore mortality\/survival of the patients of this cohort after malignant hemopathy treatment in childhood. Compare the quality of life in patients treated for malignant hemopathy to the one of subjects of same gender and age, control subjects in good health or suffering of chronic diseases. Project perspectives: Concerning literature, knowledge of the determinants of health condition and quality of life in patients after a malignant hemopathy treatment during childhood is today too fragmented to propose care strategies to improve the future of these children. Taking into account the constitution limits of the Childhood Cancer Survivor Study, the cohort LEA showed its feasibility on the period 2004-2013. Nevertheless, today it\u2019s necessary to enlarge the representative base of this cohort, joining to the project the large care centers for children malignant hemopathies in France, and creating a more multi-disciplinary research consortium (HOPE-EPI). Funding requested in the context of ANR (Great loan) aim to carry on the work realized and to improve the program on the following main points: rise of the number of patients included, taking into account of largest panel of determinants, association with new clinical research teams. A partnership with the national register of children malignant hemopathies (directed by J.Clavel) will be established, allowing to optimize completeness of the active thread. Moreover, actual large multi-central French protocols for children lymphoblastic and myeloblastic acute leukemia treatment (EORTC, FRALLE, ELAM) are represented in the project by the inclusion of new centers.","abstract":"","coll_dates":[{"start":"2004-01-01"}],"nation":[{"name":"France","abbreviation":"fr","extLink":{"vocab":"ISO","vocabURI":"fr"}}],"geog_coverage":"","analysis_unit":"Individuals","universe":"{\n    \"level_sex_clusion_I\": [\n        {\n            \"value\": \"Male\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D008297\"\n            }\n        },\n        {\n            \"value\": \"Female\",\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\": \"Child, Preschool (2 to 5 years)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D002675\"\n            }\n        },\n        {\n            \"value\": \"Child (6 to 12 years)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D002648\"\n            }\n        },\n        {\n            \"value\": \"Young Adult (19 to 24 years)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D055815\"\n            }\n        },\n        {\n            \"value\": \"Adult (25 to 44 years)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D000328\"\n            }\n        },\n        {\n            \"value\": \"Middle Aged (45 to 64 years)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D008875\"\n            }\n        }\n    ],\n    \"level_type_clusion_I\": \"Patients population\",\n    \"level_type_clusion_other\": \"\",\n    \"clusion_I\": \"Patients with lymphoma, acute lymphoblastic and myeloblastic leukemia, aged less than 18 at the moment of the diagnosis, and diagnosed after January 1980. Patients are in a condition of hematological remission, and the treatment of the acute leukemia has begun in one of the investigation centers. Other criteria: resident in France, agree to participate, or parents agree for their minor children participation.\",\n    \"clusion_E\": \"\"\n}","data_kind":"['Clinical data','Participant-reported health data','Biological data','Paraclinical data (non-biological) : Imaging']","quality_statement":{"standards":[{"name":"","committee":"","governance":""}],"other_quality_statement":""}},"study_development":{"development_activity":[{"activity_type":"primary evaluation","activity_description":"Health event\/morbidity\r\nQuality of life\/health perception"}]},"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\":\"MeasurementsAndTests.Psychological\",\"vocab\":\"CESSDA\"},\"value\":\"Psychological tests\/clinical scales (depression, cognition, quality of life, etc.)\"}"],"research_instrument":"Access on specific project only","sources":[],"target_sample_size":"[1000-10000[ individuals","response_rate":"2385 patients (2003+2007+2008+2009+2010+2011+2012+2013)"},"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\"}]}"},"dataset_use":{"restrictions":"","conditions":"","conf_dec":[{"txt":""}],"spec_perm":[{"txt":"","required":""}],"contact":[{"name":""}],"deposit_req":"","cit_req":""},"notes":""}},"additional":{"IsImport":true,"versionLang":"en","originLang":"en","autoTranslation":false,"status":"imported","creationDate":"28-03-2012","lastUpdatedAuto":null,"lastUpdatedManual":"07-09-2020","isContributorPI":"No","contributorName":"Fran\u00e7oise VION-DURY","contributorAffiliation":"UNIVERSITE D'AIX MARSEILLE","addTeamMember":"","obtainedAuthorization":{"otherAuthorizingAgency":[]},"relatedDocument":[{"type":"","title":"Liste des publications dans HAL","link":"http:\/\/tinyurl.com\/Publi-HAL-LEA"}],"regulatoryRequirements":{"conformityDeclaration":""},"fundingAgent":{"fundingAgentType":["Public (France)","Public (France)","Public (France)","Public (France)","Private non-profit","Industry","Private non-profit","Public (France)","Private non-profit","Public (France)","Industry","Public (France)","Private non-profit","Public (France)"],"otherFundingAgentType":["","","","","","","","","","","","","",""]},"sponsor":{"sponsorType":["Public (France)"],"otherSponsorType":[""]},"governance":{"committee":"Yes"},"collaborations":{"networkConsortium":""},"theme":{"complementaryInformation":"","RareDiseases":""},"activeFollowUp":{"isActiveFollowUp":"Yes","followUpModeOther":""},"interventionalStudy":{"researchPurpose":[],"trialPhase":[],"interventionalStudyModel":"","isClinicalTrial":"","otherResearchPurpose":""},"isInclusionGroups":"","allocation":{"allocationMode":"","allocationUnit":""},"masking":{"maskingType":"","blindedMaskingDetails":[]},"arms":[],"intervention":[],"inclusionGroups":[],"collectionProcess":{"collectionModeDetails":"For the incident cases, data collection is organized in a prospective way at fixed term from the initial date of the diagnosis. For the prevalent cases, data collected are similar to the ones collected for the incident cases. The only difference is the collection method, which is retrospective for events concerning the period before the centers participation to LEA program (information concerning diagnosis, treatments set up, health occurence including death, relapses, organic sequelae of treatments), while it\u2019s in a perspective way for incident cases.Data collected concern explanatory variables characterizing patients\u2019 health condition and quality of life, and on the other hand variables describing factors considered as potentials determinants. Between these potential determinants, will be considered factors defined at the individual level (clinic, demographic\u2026) but also population factors (environment\u2026).Data collected:- socio-demographic and socio-economic concerning the patient and its family;- clinical and therapeutic data concerning the disease (LA): nature, age at diagnosis, severity, treatments, recovery distance\u2026);- concerning clinical examination and eventual organic sequelae: height and weight growth puberty, fertility, thyroid function, visual function, cardiac function, viral contamination, pulmonary function, bone metabolism, iron metabolism, metabolic syndrome, other sequelae (diabetes, osteonecrosis, chronic renal insufficiency, alopecia, central nervous system\u2026);- psychological, behavioral and cognitive; - concerning quality of life in patients and their relatives;- concerning patient relation with health care system (care access and satisfaction);","collectionModeOther":""},"dataCollection":{"inclusionStrategyOther":"","samplingModeOther":"","recruitmentSourceOther":"","otherDocumentation":""},"dataCollectionIntegration":{"isDataIntegration":"No"},"geographicalCoverage":{"geoDetail":"At the beginning, the project implied pediatric and pediatric hematology departments of the CHU Marseille (PACA-West and Corse) and CHU Nancy (Lorraine). As a second step, the teams of CHU Nice (PACA-East), Clermont Ferrand (Auvergne) and Grenoble (Rh\u00f4ne-Alpes) joined the project, and have been included respectively in 2007, 2008, and 2009. In 2010, the Lyon Institute of Hematology and Pediatric Oncology joined the project, followed in 2011 by 3 Parisian centers (St. Louis, Robert Debr\u00e9, Trousseau) and St. Etienne (Rh\u00f4ne-Alpes). Finally, the CHU of Rennes (Bretagne) and Montpellier (Languedoc-Roussillon) began to include in 2012. Half -2012, the CHU of Bordeaux and Strasbourg committed to the preparatory phase for inclusion."},"dataTypes":{"clinicalDataDetails":"","biologicalDataDetails":"Concerning medical follow-up of patients, blood samples are taken and data concerning biological usual parameters are collected.","isDataInBiobank":"Yes","biobankContent":[],"biobankContentOther":"","dataTypeOther":""},"variableDictionnary":{"variableDictionnaryAvailable":"","variableDictionnaryLink":""},"dataQuality":{"otherDocumentation":""},"mockSample":{"mockSampleAvailable":"","mockSampleLocation":""},"thirdPartySource":{"otherSourceType":[]},"isHealthTheme":"Yes","fileDscr":{"fileTxt":{"fileCitation":{"titlStmt":{"IDno":[]}}}}},"schematype":"survey"}