Nctid:
NCT06232967
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-12-27"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D008175", "term"=>"Lung Neoplasms"}, {"id"=>"D002289", "term"=>"Carcinoma, Non-Small-Cell Lung"}], "ancestors"=>[{"id"=>"D012142", "term"=>"Respiratory Tract Neoplasms"}, {"id"=>"D013899", "term"=>"Thoracic Neoplasms"}, {"id"=>"D009371", "term"=>"Neoplasms by Site"}, {"id"=>"D009369", "term"=>"Neoplasms"}, {"id"=>"D008171", "term"=>"Lung Diseases"}, {"id"=>"D012140", "term"=>"Respiratory Tract Diseases"}, {"id"=>"D002283", "term"=>"Carcinoma, Bronchogenic"}, {"id"=>"D001984", "term"=>"Bronchial Neoplasms"}], "browseLeaves"=>[{"id"=>"M5546", "name"=>"Carcinoma, Non-Small-Cell Lung", "asFound"=>"Non-small Cell Lung Cancer", "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"=>"ACTUAL", "count"=>223}, "patientRegistry"=>false}, "statusModule"=>{"overallStatus"=>"COMPLETED", "startDateStruct"=>{"date"=>"2023-04-01", "type"=>"ACTUAL"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-06", "completionDateStruct"=>{"date"=>"2023-12-30", "type"=>"ACTUAL"}, "lastUpdateSubmitDate"=>"2024-06-26", "studyFirstSubmitDate"=>"2024-01-20", "studyFirstSubmitQcDate"=>"2024-01-22", "lastUpdatePostDateStruct"=>{"date"=>"2024-06-27", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-01-31", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2023-10-30", "type"=>"ACTUAL"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"Disease-specific survival (DSS)", "timeFrame"=>"Up to 8 years", "description"=>"The duration from the day of surgery to the the last follow-up visit or to death specifically caused by NSCLC."}], "secondaryOutcomes"=>[{"measure"=>"Progression-free survival (PFS)", "timeFrame"=>"Up to 8 years", "description"=>"The duration of survival with no evidence of progression of the disease."}]}, "oversightModule"=>{"oversightHasDmc"=>false, "isFdaRegulatedDrug"=>false, "isFdaRegulatedDevice"=>false}, "conditionsModule"=>{"conditions"=>["Non-small-cell Lung Cancer (NSCLC)"]}, "descriptionModule"=>{"briefSummary"=>"The goal of this mutli-center observational study is toinvestigate the impact of primary tumor resection (PTR) on the long-term survival of patients with non-small-cell lung cancer (NSCLC) and dry pleural dissemination (DPD). The main question it aims to answer is: whether primary tumor resection improve long-term survival of NSCLC patients with dry pleural dissemination.", "detailedDescription"=>"Non-small-cell lung cancer (NSCLC) patients with dry pleural dissemination have poor survival rates and are generally contraindicated for surgery. Previous single-center retrospective studies have suggested that these patients may benefit from primary tumor resection (PTR). However, the evidence supporting PTR is still limited, especially in the era of targeted therapy. This study aimed to investigate the impact of PTR on the long-term survival of patients with NSCLC and DPD."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["ADULT", "OLDER_ADULT"], "maximumAge"=>"80 years", "minimumAge"=>"18 years", "samplingMethod"=>"NON_PROBABILITY_SAMPLE", "studyPopulation"=>"From January 2016 to December 2023, a total of 204 consecutive NSCLC patients with surgically confirmed DPD were collected retrospectively from three high-volume centers in China. Data were obtained by reviewing medical records.", "healthyVolunteers"=>false, "eligibilityCriteria"=>"Inclusion Criteria:\n\n(1) pathologically confirmed primary NSCLC with malignant pleural dissemination, (2) no preoperative treatment, (3) age 80 years or younger, (4) clinicopathologic data and follow-up results were complete.\n\nExclusion Criteria:\n\n(1) pleural effusion, contralateral lung metastasis or distant metastasis revealed preoperatively, and (2) with a history of other malignant disease."}, "identificationModule"=>{"nctId"=>"NCT06232967", "briefTitle"=>"PPIO-006 Primary Tumor Resection for IVa NSCLC", "organization"=>{"class"=>"OTHER", "fullName"=>"Daping Hospital and the Research Institute of Surgery of the Third Military Medical University"}, "officialTitle"=>"Long-term Outcome of Primary Tumor Resection in Non-Small-Cell Lung Cancer Patients With Dry Pleural Dissemination: A Multi-center Study", "orgStudyIdInfo"=>{"id"=>"Wei Guo"}}, "armsInterventionsModule"=>{"armGroups"=>[{"label"=>"Primary tumor resection (PTR group)", "description"=>"includes wedge resection, segmentectomy, or lobectomy.", "interventionNames"=>["Procedure: Primary tumor resection or not"]}, {"label"=>"Exploratory thoracotomy (ET group)", "description"=>"JSimply open and close surgery."}], "interventions"=>[{"name"=>"Primary tumor resection or not", "type"=>"PROCEDURE", "description"=>"For patients with non-small-cell lung cancer (NSCLC) and dry pleural dissemination, surgical decisions to perform exploratory thoracotomy only or primary tumor resection with wedge resection, segmentectomy, or lobectomy were based on surgeon experience and patient preference.", "armGroupLabels"=>["Primary tumor resection (PTR group)"]}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"400042", "city"=>"Chongqing", "state"=>"Chongqing", "country"=>"China", "facility"=>"Army Medical Center of the People's Liberation Army", "geoPoint"=>{"lat"=>29.56278, "lon"=>106.55278}}], "overallOfficials"=>[{"name"=>"Wei Guo, PhD", "role"=>"PRINCIPAL_INVESTIGATOR", "affiliation"=>"Daping Hospital and the Research Institute of Surgery of the Third Military Medical University"}]}, "ipdSharingStatementModule"=>{"ipdSharing"=>"NO"}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"Daping Hospital and the Research Institute of Surgery of the Third Military Medical University", "class"=>"OTHER"}, "collaborators"=>[{"name"=>"First Affiliated Hospital of Chongqing Medical University", "class"=>"OTHER"}], "responsibleParty"=>{"type"=>"PRINCIPAL_INVESTIGATOR", "investigatorTitle"=>"PhD.", "investigatorFullName"=>"WEI GUO", "investigatorAffiliation"=>"Daping Hospital and the Research Institute of Surgery of the Third Military Medical University"}}}}
