Nctid:
NCT06221800
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-10-04"}, "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"=>"M11172", "name"=>"Lung Neoplasms", "asFound"=>"Lung Cancer", "relevance"=>"HIGH"}, {"id"=>"M5546", "name"=>"Carcinoma, Non-Small-Cell Lung", "asFound"=>"Non-small Cell 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"}]}, "interventionBrowseModule"=>{"browseLeaves"=>[{"id"=>"M2889", "name"=>"Tyrosine Kinase Inhibitors", "relevance"=>"LOW"}, {"id"=>"T22", "name"=>"Tyrosine", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"All Drugs and Chemicals", "abbrev"=>"All"}, {"name"=>"Amino Acids", "abbrev"=>"AA"}]}}, "protocolSection"=>{"designModule"=>{"studyType"=>"OBSERVATIONAL", "designInfo"=>{"timePerspective"=>"PROSPECTIVE", "observationalModel"=>"COHORT"}, "enrollmentInfo"=>{"type"=>"ESTIMATED", "count"=>82}, "patientRegistry"=>false}, "statusModule"=>{"overallStatus"=>"RECRUITING", "startDateStruct"=>{"date"=>"2024-01-31", "type"=>"ACTUAL"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-02", "completionDateStruct"=>{"date"=>"2025-12", "type"=>"ESTIMATED"}, "lastUpdateSubmitDate"=>"2024-02-01", "studyFirstSubmitDate"=>"2024-01-15", "studyFirstSubmitQcDate"=>"2024-01-15", "lastUpdatePostDateStruct"=>{"date"=>"2024-02-05", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-01-24", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2025-12", "type"=>"ESTIMATED"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"Gut microbiomes in advanced/metastatic NSCLC patients", "timeFrame"=>"Up to 2 years", "description"=>"To summarize the diversity and composition of gut microbiomes at baseline or prior to initiation of therapy"}], "secondaryOutcomes"=>[{"measure"=>"Change in microbiome diversity and composition from baseline (prior to start of therapy) to first post-treatment evaluation scan.", "timeFrame"=>"Up to 2 years", "description"=>"Relative difference (and if necessary, relative ratio) between baseline and the first post-evaluation scan"}, {"measure"=>"Clinical Response Rate (RR)", "timeFrame"=>"Up to 2 years", "description"=>"Defined according to RECIST v1.1 criteria"}, {"measure"=>"Progression-Free Survival (PFS)", "timeFrame"=>"Up to 2 years", "description"=>"Duration from the start date of treatment to the date of progression or death from any cause, whichever occurs first."}, {"measure"=>"Overall survival (OS)", "timeFrame"=>"Up to 2 years", "description"=>"Duration from the start date of treatment to the date of death from any cause."}]}, "oversightModule"=>{"isFdaRegulatedDrug"=>false, "isFdaRegulatedDevice"=>false}, "conditionsModule"=>{"conditions"=>["Non Small Cell Lung Cancer"]}, "descriptionModule"=>{"briefSummary"=>"This is a pilot study collecting data on the diversity and composition of gut microbiomes in subjects with advanced/metastatic Non-Small Cell Lung Cancer (NSCLC) while receiving treatment for NSCLC."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["ADULT", "OLDER_ADULT"], "minimumAge"=>"18 years", "samplingMethod"=>"NON_PROBABILITY_SAMPLE", "studyPopulation"=>"Patient with advanced/metastatic non-small cell lung cancer (NSCLC)", "healthyVolunteers"=>false, "eligibilityCriteria"=>"Inclusion Criteria:\n\n* 1. Advanced/Metastatic non-small cell lung cancer NSCLC patients.\n* 2. The patient himself/herself must be 18 years of age on day of signing informed consent.\n* 3. The subject has signed the informed consent form.\n* 4. The patient must be eligible to receive FDA approved and non-approved PD1 inhibitors (i.e. pembrolizumab, nivolumab) or PDL1 inhibitor (i.e. atezolizumab, durvalumab) either single agent or as combination therapy with chemotherapy, or be eligible to receive FDA approved and non-approved tyrosine kinase inhibitors.\n* 5. The subject will be registered upon submission of the samples. When submitted on separate dates, the submission occurring later will be considered the date of registration\n\nExclusion Criteria:\n\n* 1. Those subjects who are determined clinically unstable of the participation of this study as determined by the PI or treating physician will be excluded and asked to focus on their treatment."}, "identificationModule"=>{"nctId"=>"NCT06221800", "briefTitle"=>"Assess Diversity of Gut Microbiome in Met NSCLC in Correlation to Tx & Adverse Effects", "organization"=>{"class"=>"OTHER", "fullName"=>"University of California, Irvine"}, "officialTitle"=>"A Pilot Study to Assess the Diversity of Gut Microbiome in Metastatic Non-Small Cell Lung Cancer (NSCLC) in Correlation to Treatment Effects and Adverse Effects", "orgStudyIdInfo"=>{"id"=>"3887"}, "secondaryIdInfos"=>[{"id"=>"UCI 22-86", "type"=>"OTHER", "domain"=>"UCI CFCCC"}]}, "armsInterventionsModule"=>{"armGroups"=>[{"label"=>"Treatment with PD1/L1 monotherapy", "interventionNames"=>["Diagnostic Test: Microbiome"]}, {"label"=>"Treatment with PD1/L1 + chemotherapy", "interventionNames"=>["Diagnostic Test: Microbiome"]}, {"label"=>"Treatment with Tyrosine Kinase Inhibitor", "interventionNames"=>["Diagnostic Test: Microbiome"]}], "interventions"=>[{"name"=>"Microbiome", "type"=>"DIAGNOSTIC_TEST", "description"=>"Stool and saliva samples will be collected", "armGroupLabels"=>["Treatment with PD1/L1 + chemotherapy", "Treatment with PD1/L1 monotherapy", "Treatment with Tyrosine Kinase Inhibitor"]}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"92868", "city"=>"Orange", "state"=>"California", "status"=>"RECRUITING", "country"=>"United States", "contacts"=>[{"name"=>"Misako Nagasaka, MD, PhD", "role"=>"CONTACT", "email"=>"ucstudy@uci.edu", "phone"=>"877-827-8839"}], "facility"=>"Chao Family Comprehensive Cancer Center University of California, Irvine", "geoPoint"=>{"lat"=>33.78779, "lon"=>-117.85311}}], "centralContacts"=>[{"name"=>"Chao Family Comprehensive Cancer Center University of California, Irvine", "role"=>"CONTACT", "email"=>"ucstudy@uci.edu", "phone"=>"1-877-827-8839"}, {"name"=>"University of California Irvine Medical", "role"=>"CONTACT"}], "overallOfficials"=>[{"name"=>"Misako Nagasaka, MD,PhD", "role"=>"PRINCIPAL_INVESTIGATOR", "affiliation"=>"Chao Family Comprehensive Cancer Center"}]}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"University of California, Irvine", "class"=>"OTHER"}, "responsibleParty"=>{"type"=>"PRINCIPAL_INVESTIGATOR", "investigatorTitle"=>"Associate Clinical Professor", "investigatorFullName"=>"Misako Nagasaka", "investigatorAffiliation"=>"University of California, Irvine"}}}}
