Nctid:
NCT06617390
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-10-03"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D000008175", "term"=>"Lung Neoplasms"}, {"id"=>"D000002289", "term"=>"Carcinoma, Non-Small-Cell Lung"}], "ancestors"=>[{"id"=>"D000012142", "term"=>"Respiratory Tract Neoplasms"}, {"id"=>"D000013899", "term"=>"Thoracic Neoplasms"}, {"id"=>"D000009371", "term"=>"Neoplasms by Site"}, {"id"=>"D000009369", "term"=>"Neoplasms"}, {"id"=>"D000008171", "term"=>"Lung Diseases"}, {"id"=>"D000012140", "term"=>"Respiratory Tract Diseases"}, {"id"=>"D000002283", "term"=>"Carcinoma, Bronchogenic"}, {"id"=>"D000001984", "term"=>"Bronchial Neoplasms"}], "browseLeaves"=>[{"id"=>"M5546", "name"=>"Carcinoma, Non-Small-Cell Lung", "asFound"=>"NSCLC", "relevance"=>"HIGH"}, {"id"=>"M11172", "name"=>"Lung Neoplasms", "asFound"=>"Lung Cancer", "relevance"=>"HIGH"}, {"id"=>"M5534", "name"=>"Carcinoma", "relevance"=>"LOW"}, {"id"=>"M14979", "name"=>"Respiratory Tract Neoplasms", "relevance"=>"LOW"}, {"id"=>"M16658", "name"=>"Thoracic Neoplasms", "relevance"=>"LOW"}, {"id"=>"M11168", "name"=>"Lung Diseases", "relevance"=>"LOW"}, {"id"=>"M14977", "name"=>"Respiratory Tract Diseases", "relevance"=>"LOW"}, {"id"=>"M5540", "name"=>"Carcinoma, Bronchogenic", "relevance"=>"LOW"}, {"id"=>"M5260", "name"=>"Bronchial Neoplasms", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Neoplasms", "abbrev"=>"BC04"}, {"name"=>"Respiratory Tract (Lung and Bronchial) Diseases", "abbrev"=>"BC08"}, {"name"=>"All Conditions", "abbrev"=>"All"}]}}, "protocolSection"=>{"designModule"=>{"studyType"=>"OBSERVATIONAL", "designInfo"=>{"timePerspective"=>"RETROSPECTIVE", "observationalModel"=>"COHORT"}, "enrollmentInfo"=>{"type"=>"ESTIMATED", "count"=>1200}, "patientRegistry"=>false}, "statusModule"=>{"overallStatus"=>"ENROLLING_BY_INVITATION", "startDateStruct"=>{"date"=>"2024-08-30", "type"=>"ACTUAL"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-09", "completionDateStruct"=>{"date"=>"2025-03-31", "type"=>"ESTIMATED"}, "lastUpdateSubmitDate"=>"2024-09-25", "studyFirstSubmitDate"=>"2024-09-25", "studyFirstSubmitQcDate"=>"2024-09-25", "lastUpdatePostDateStruct"=>{"date"=>"2024-09-27", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-09-27", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2024-12-31", "type"=>"ESTIMATED"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"Percentage of real-world treatment regimens for second- or third-line therapy in patients with advanced NSCLC", "timeFrame"=>"40 months"}]}, "oversightModule"=>{"oversightHasDmc"=>false, "isFdaRegulatedDrug"=>false, "isFdaRegulatedDevice"=>false}, "conditionsModule"=>{"keywords"=>["NSCLC", "Lung Cancer"], "conditions"=>["Non-small Cell Lung Cancer (NSCLC)"]}, "descriptionModule"=>{"briefSummary"=>"This study will retrospectively collect data of patients with advanced non-small cell lung cancer who have received at least 2 line treatment to investigate treatment patterns, relevant outcomes, and biomarkers detection patterns in Chinese patients with Actionable Genomic Alterations (AGA) or non-AGA."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["ADULT", "OLDER_ADULT"], "minimumAge"=>"18 years", "samplingMethod"=>"NON_PROBABILITY_SAMPLE", "studyPopulation"=>"Participants with advanced NSCLC who have received at least 2L treatment between September 1, 2019, and December 31, 2022.", "healthyVolunteers"=>false, "eligibilityCriteria"=>"Inclusion Criteria:\n\n1. Participants aged ≥18 years when diagnosed with advanced NSCLC.\n2. Histologically or cytologically confirmed stage IV NSCLC.\n3. For non-AGA participants , second- or third-line systemic treatment occurred between September 1, 2019 and December 31, 2022, and participants received corresponding immunotherapy in the first or second line.\n4. For AGA participants , second- or third-line systemic treatment occurred between September 1, 2019 and December 31, 2022. Among them, participants with documented positive result for EGFR, ALK, or ROS1 testing received corresponding targeted therapy in the first or second line.\n\nExclusion Criteria:\n\nThis study excludes participants who met any of the following criteria.\n\n1. Having records of participation or past participation in clinical trial for lung cancer within the data collection period of the study.\n2. Participants with a concomitant cancer at the time of diagnosis of NSCLC (except for non-metastatic non-melanoma skin cancers, in situ or benign neoplasms). Occurrence of cancer within 5 years after NSCLC diagnosis will be considered as secondary cancer.\n3. Histology of the tumor is small cell lung cancer, neuroendocrine in origin, or a mixed histologic type with small cell and non-small cell lung cancers.\n4. Participants with significantly missing medical record data or patients deemed inappropriate for inclusion by investigators."}, "identificationModule"=>{"nctId"=>"NCT06617390", "acronym"=>"RECAP", "briefTitle"=>"A Study of Real-world Treatment Patterns and Outcomes in Chinese Advanced NSCLC Patients Who Previously Received at Least 2 Line Treatments", "organization"=>{"class"=>"INDUSTRY", "fullName"=>"Daiichi Sankyo"}, "officialTitle"=>"Real-world Treatment Patterns and Outcomes in Chinese Advanced NSCLC Patients Who Previously Received at Least 2 Line Treatment: a Multi-center, Non-interventional and Retrospective Real-world Study (RECAP)", "orgStudyIdInfo"=>{"id"=>"DS1062-0001-NIS-MA"}}, "armsInterventionsModule"=>{"armGroups"=>[{"label"=>"AGA Cohort", "description"=>"NSCLC participants with AGA that received second-line or above therapies treatment.", "interventionNames"=>["Other: No drug"]}, {"label"=>"Non-AGA Cohort", "description"=>"NSCLC participants with non-AGA that received second-line or above therapies treatment.", "interventionNames"=>["Other: No drug"]}], "interventions"=>[{"name"=>"No drug", "type"=>"OTHER", "description"=>"This is a non-interventional study and no study drug will be provided.", "armGroupLabels"=>["AGA Cohort", "Non-AGA Cohort"]}]}, "contactsLocationsModule"=>{"locations"=>[{"city"=>"Beijing", "country"=>"China", "facility"=>"Beijing Cancer Hospital", "geoPoint"=>{"lat"=>39.9075, "lon"=>116.39723}}, {"city"=>"Fuzhou", "country"=>"China", "facility"=>"The First Affiliated Hospital of Fujian Medical University", "geoPoint"=>{"lat"=>26.06139, "lon"=>119.30611}}, {"city"=>"Guangzhou", "country"=>"China", "facility"=>"Sun Yat-sen University Cancer Center", "geoPoint"=>{"lat"=>23.11667, "lon"=>113.25}}, {"city"=>"Jinan", "country"=>"China", "facility"=>"Affiliated Cancer Hospital of Shandong First Medical University", "geoPoint"=>{"lat"=>36.66833, "lon"=>116.99722}}, {"city"=>"Shenyang", "country"=>"China", "facility"=>"Liaoning Cancer Hospital & Institute", "geoPoint"=>{"lat"=>41.79222, "lon"=>123.43278}}, {"city"=>"Suzhou", "country"=>"China", "facility"=>"The First Affiliated Hospital of Soochow University", "geoPoint"=>{"lat"=>31.30408, "lon"=>120.59538}}]}, "ipdSharingStatementModule"=>{"ipdSharing"=>"NO"}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"Daiichi Sankyo", "class"=>"INDUSTRY"}, "responsibleParty"=>{"type"=>"SPONSOR"}}}}
