Nctid:
NCT06612827
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-12-20"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D002277", "term"=>"Carcinoma"}], "ancestors"=>[{"id"=>"D009375", "term"=>"Neoplasms, Glandular and Epithelial"}, {"id"=>"D009370", "term"=>"Neoplasms by Histologic Type"}, {"id"=>"D009369", "term"=>"Neoplasms"}], "browseLeaves"=>[{"id"=>"M5534", "name"=>"Carcinoma", "asFound"=>"Carcinoma", "relevance"=>"HIGH"}, {"id"=>"M12320", "name"=>"Neoplasms, Glandular and Epithelial", "relevance"=>"LOW"}, {"id"=>"M12315", "name"=>"Neoplasms by Histologic Type", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Neoplasms", "abbrev"=>"BC04"}, {"name"=>"All Conditions", "abbrev"=>"All"}]}}, "protocolSection"=>{"designModule"=>{"bioSpec"=>{"retention"=>"SAMPLES_WITH_DNA", "description"=>"tumor and serum samples"}, "studyType"=>"OBSERVATIONAL", "designInfo"=>{"timePerspective"=>"PROSPECTIVE", "observationalModel"=>"COHORT"}, "enrollmentInfo"=>{"type"=>"ESTIMATED", "count"=>15}, "patientRegistry"=>false}, "statusModule"=>{"overallStatus"=>"NOT_YET_RECRUITING", "startDateStruct"=>{"date"=>"2024-12-15", "type"=>"ESTIMATED"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-11", "completionDateStruct"=>{"date"=>"2031-12-15", "type"=>"ESTIMATED"}, "lastUpdateSubmitDate"=>"2024-11-04", "studyFirstSubmitDate"=>"2024-09-23", "studyFirstSubmitQcDate"=>"2024-09-23", "lastUpdatePostDateStruct"=>{"date"=>"2024-11-07", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-09-25", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2027-12-15", "type"=>"ESTIMATED"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"Rate of establishment of exploitable tumor organoids", "timeFrame"=>"through study completion, an average of 3 years", "description"=>"Rate of establishment usable tumor organoids for predictive tests of response to treatment."}]}, "oversightModule"=>{"isUsExport"=>false, "oversightHasDmc"=>false, "isFdaRegulatedDrug"=>false, "isFdaRegulatedDevice"=>false}, "conditionsModule"=>{"keywords"=>["tumoroid", "organoid"], "conditions"=>["Undifferentiated Carcinoma"]}, "descriptionModule"=>{"briefSummary"=>"The study is based on the constitution of a collection of tumor and blood samples for the development of tumoroid for functional tests to predict clinical response to treatment."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["ADULT", "OLDER_ADULT"], "minimumAge"=>"18 years", "samplingMethod"=>"NON_PROBABILITY_SAMPLE", "studyPopulation"=>"Patient with undifferentiated primary carcinoma (UPC) with indication for 1st-line treatment", "healthyVolunteers"=>false, "eligibilityCriteria"=>"Inclusion Criteria:\n\n* Patient with undifferentiated primary carcinoma (UPC) with histological and immunohistochemical evidence, validated in a local and/or national UPC multidisciplinary consultation\n* Patient with indication for 1st-line treatment at the time of inclusion.\n* Patient with life expectancy greater than 3 months\n* Patient of legal age\n* Patient affiliated to a social security scheme\n* Signature of informed consent prior to any specific study procedure\n\nExclusion Criteria:\n\n* Persons deprived of their liberty or under guardianship (including curatorship)\n* Pregnant or breast-feeding patient"}, "identificationModule"=>{"nctId"=>"NCT06612827", "acronym"=>"OCAPI", "briefTitle"=>"Development of Tumor Organoids from Undifferentiated Primary Carcinomas to Guide Therapeutic Decisions", "organization"=>{"class"=>"OTHER", "fullName"=>"Centre Francois Baclesse"}, "officialTitle"=>"Development of Tumor Organoids from Undifferentiated Primary Carcinomas to Guide Therapeutic Decisions", "orgStudyIdInfo"=>{"id"=>"2024-A01326-41"}}, "armsInterventionsModule"=>{"armGroups"=>[{"label"=>"Blood and tumor collection", "description"=>"Blood and tumor collection before treatment initiation", "interventionNames"=>["Other: organoid etablishment"]}], "interventions"=>[{"name"=>"organoid etablishment", "type"=>"OTHER", "description"=>"Prior to initiation of 1st-line therapy:\n\n* Collection of an additional study-specific tumor sample for tumoroid analysis (1 fresh tumor sample)\n* A blood test blood a for tumoroid realization and :\n* Analysis of ex vivo tumoroid response to treatment and correlation with patient response in vivo\n* Analysis of correlation between in vivo and ex vivo tumor characteristics\n* Analysis of first- and second-line survival rates and overall survival", "armGroupLabels"=>["Blood and tumor collection"]}]}, "contactsLocationsModule"=>{"locations"=>[{"city"=>"Caen", "country"=>"France", "contacts"=>[{"name"=>"Zoé NEVIERE, MD", "role"=>"CONTACT", "email"=>"z.neviere@baclesse.unicancer.fr", "phone"=>"33231455050"}], "facility"=>"Centre François Baclesse", "geoPoint"=>{"lat"=>49.18585, "lon"=>-0.35912}}], "centralContacts"=>[{"name"=>"zoé NEVIERE, Medical Doctor", "role"=>"CONTACT", "email"=>"z.neviere@baclesse.unicancer.fr", "phone"=>"33231455050"}]}, "ipdSharingStatementModule"=>{"ipdSharing"=>"UNDECIDED"}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"Centre Francois Baclesse", "class"=>"OTHER"}, "responsibleParty"=>{"type"=>"SPONSOR"}}}}
