Nctid:
NCT06224296
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-10-04"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D000006949", "term"=>"Hyperlipidemias"}], "ancestors"=>[{"id"=>"D000050171", "term"=>"Dyslipidemias"}, {"id"=>"D000052439", "term"=>"Lipid Metabolism Disorders"}, {"id"=>"D000008659", "term"=>"Metabolic Diseases"}], "browseLeaves"=>[{"id"=>"M10000", "name"=>"Hyperlipidemias", "asFound"=>"Hyperlipidemia", "relevance"=>"HIGH"}, {"id"=>"M10002", "name"=>"Hyperlipoproteinemias", "relevance"=>"LOW"}, {"id"=>"M26181", "name"=>"Dyslipidemias", "relevance"=>"LOW"}, {"id"=>"M11639", "name"=>"Metabolic Diseases", "relevance"=>"LOW"}, {"id"=>"M27029", "name"=>"Lipid Metabolism Disorders", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Nutritional and Metabolic Diseases", "abbrev"=>"BC18"}, {"name"=>"All Conditions", "abbrev"=>"All"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["NA"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"allocation"=>"NA", "maskingInfo"=>{"masking"=>"NONE"}, "primaryPurpose"=>"PREVENTION", "interventionModel"=>"SINGLE_GROUP", "interventionModelDescription"=>"Subjects are self-controlled in each group."}, "enrollmentInfo"=>{"type"=>"ESTIMATED", "count"=>250}}, "statusModule"=>{"overallStatus"=>"NOT_YET_RECRUITING", "startDateStruct"=>{"date"=>"2024-03-01", "type"=>"ESTIMATED"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-01", "completionDateStruct"=>{"date"=>"2025-03-01", "type"=>"ESTIMATED"}, "lastUpdateSubmitDate"=>"2024-01-16", "studyFirstSubmitDate"=>"2024-01-16", "studyFirstSubmitQcDate"=>"2024-01-16", "lastUpdatePostDateStruct"=>{"date"=>"2024-01-25", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-01-25", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2024-12-31", "type"=>"ESTIMATED"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"Inflammatory cytokine panel", "timeFrame"=>"Baseline, day0, 1, 3, 6 month after DFPP", "description"=>"IL-2,IL-4,IL-6,IL-10, TNF-a, IFN-r, hs CRP(subjected to change)"}, {"measure"=>"Blood lipid panel", "timeFrame"=>"Baseline, day0, 1, 3, 6 month after DFPP", "description"=>"Total cholesterol, total triglycerides, low-density lipoprotein(LDL), high-density lipoprotein(HDL), lipoprotein(a)(subjected to change)"}, {"measure"=>"Toxic metal ions", "timeFrame"=>"Baseline, day0", "description"=>"Lead, mercury etc based on the specific exposure"}], "secondaryOutcomes"=>[{"measure"=>"Immune cells", "timeFrame"=>"Baseline, day0, 1, 3, 6 month after DFPP", "description"=>"TBNK, ROS, PD1/lag3/KLRG1/CD57 etc (subjected to change)"}]}, "oversightModule"=>{"oversightHasDmc"=>false, "isFdaRegulatedDrug"=>false, "isFdaRegulatedDevice"=>false}, "conditionsModule"=>{"keywords"=>["DFPP", "Blood Purification"], "conditions"=>["Sub-healthy", "Hyperlipidemia", "Toxic Metal Ions Accumulation"]}, "descriptionModule"=>{"briefSummary"=>"This study investigates whether using Double Filtration Plasmapheresis (DFPP) could improve the overall health of adults through removing inflammatory cytokines, lipids and toxic metal ions from peripheral blood. It's also postulated that DFPP could boost immune cells through removing certain inflammatory cytokines and blood lipids.", "detailedDescription"=>"In this study, 3 groups of subjects will be recruited based on the indications of using DFPP. Estimated 100 sub-healthy subjects will be enrolled in the Group A (inflammatory cytokine group), the inflammatory cytokine panel will be tested at baseline, immediately and 1, 3, 6 months after using DFPP. Similarly estimated 100 subjects with elevated blood lipid or cholesterol will be enrolled in Group B (lipids group), the lipid panel will be tested at the same timeline as Group A. Estimated 50 subjects who are likely to have toxic metal ions accumulated (eg. using make-up for long term, working exposure) will be enrolled in Group C (toxic metal ions group), the specific metal ions will be tested before and after using DFPP. Tests related to immune cells will also be conducted in Group A and B at baseline, immediately and 1, 3, 6 months after using DFPP."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["ADULT", "OLDER_ADULT"], "maximumAge"=>"85 years", "minimumAge"=>"18 years", "healthyVolunteers"=>true, "eligibilityCriteria"=>"Inclusion Criteria:\n\n* Male/females of 18 to 85 years of age. For Group B, subjects should have elevated blood lipid or cholesterol, which could be a. hyperlipidemia; b. higher than the normal range but not high enough to be diagnosed as hyperlipidemia. Able to provide written Informed Consent. Able to follow verbal and written study directions.\n\nExclusion Criteria:\n\n* Have sever liver and kidney dysfunction. Have cardiopulmonary insufficiency. Have solid or blood tumor. Pregnancy or breastfeeding women."}, "identificationModule"=>{"nctId"=>"NCT06224296", "briefTitle"=>"The Exploratory Study About the Effect of Using Double Filtration Plasmapheresis (DFPP) Removing Inflammatory Cytokines, Lipids and Toxic Metal Ions in Peripheral Blood in Adults", "organization"=>{"class"=>"INDUSTRY", "fullName"=>"Shanghai Cell Therapy Group Co.,Ltd"}, "officialTitle"=>"The Exploratory Study About the Effect of Using Double Filtration Plasmapheresis (DFPP) Removing Inflammatory Cytokines, Lipids and Toxic Metal Ions in Peripheral Blood in Adults", "orgStudyIdInfo"=>{"id"=>"BZXJ2401-A-01"}}, "armsInterventionsModule"=>{"armGroups"=>[{"type"=>"EXPERIMENTAL", "label"=>"Group A: Inflammatory cytokine group", "description"=>"Self-control", "interventionNames"=>["Device: DFPP"]}, {"type"=>"EXPERIMENTAL", "label"=>"Group B: Lipid group", "description"=>"Self-control", "interventionNames"=>["Device: DFPP"]}, {"type"=>"EXPERIMENTAL", "label"=>"Group C: Toxic metal ions group", "description"=>"Self-control", "interventionNames"=>["Device: DFPP"]}], "interventions"=>[{"name"=>"DFPP", "type"=>"DEVICE", "description"=>"One session of blood purification using DFPP to remove inflammatory cytokines in peripheral blood.", "armGroupLabels"=>["Group A: Inflammatory cytokine group"]}, {"name"=>"DFPP", "type"=>"DEVICE", "description"=>"One session of blood purification using DFPP to remove lipids in peripheral blood.", "armGroupLabels"=>["Group B: Lipid group"]}, {"name"=>"DFPP", "type"=>"DEVICE", "description"=>"One session of blood purification using DFPP to remove toxic metal ions.", "armGroupLabels"=>["Group C: Toxic metal ions group"]}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"200240", "city"=>"Shanghai", "state"=>"Shanghai", "country"=>"China", "contacts"=>[{"name"=>"Yongqiang Ren", "role"=>"CONTACT", "email"=>"renyq@shcell.com", "phone"=>"13621247084"}, {"name"=>"Yongqiang Ren", "role"=>"PRINCIPAL_INVESTIGATOR"}], "facility"=>"Shanghai Mengchao Cancer Hospital", "geoPoint"=>{"lat"=>31.22222, "lon"=>121.45806}}], "centralContacts"=>[{"name"=>"Yongqiang Ren", "role"=>"CONTACT", "email"=>"renyq@shcell.com", "phone"=>"13621247084"}, {"name"=>"Meina Jiang", "role"=>"CONTACT", "email"=>"jiangmn@shcell.com", "phone"=>"18616900240"}]}, "ipdSharingStatementModule"=>{"ipdSharing"=>"NO"}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"Shanghai Cell Therapy Group Co.,Ltd", "class"=>"INDUSTRY"}, "collaborators"=>[{"name"=>"Shanghai Mengchao Cancer Hospital", "class"=>"OTHER"}], "responsibleParty"=>{"type"=>"SPONSOR"}}}}
