Nctid:
NCT06228937
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-10-01"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D000008209", "term"=>"Lymphedema"}, {"id"=>"D000008205", "term"=>"Lymphangitis"}], "ancestors"=>[{"id"=>"D000008206", "term"=>"Lymphatic Diseases"}], "browseLeaves"=>[{"id"=>"M14850", "name"=>"Recurrence", "relevance"=>"LOW"}, {"id"=>"M11206", "name"=>"Lymphedema", "asFound"=>"Lymphedema", "relevance"=>"HIGH"}, {"id"=>"M11202", "name"=>"Lymphangitis", "asFound"=>"Lymphangitis", "relevance"=>"HIGH"}, {"id"=>"M11203", "name"=>"Lymphatic Diseases", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Symptoms and General Pathology", "abbrev"=>"BC23"}, {"name"=>"All Conditions", "abbrev"=>"All"}, {"name"=>"Blood and Lymph Conditions", "abbrev"=>"BC15"}]}}, "protocolSection"=>{"designModule"=>{"studyType"=>"OBSERVATIONAL", "designInfo"=>{"timePerspective"=>"PROSPECTIVE", "observationalModel"=>"COHORT"}, "enrollmentInfo"=>{"type"=>"ESTIMATED", "count"=>60}, "patientRegistry"=>false}, "statusModule"=>{"overallStatus"=>"RECRUITING", "startDateStruct"=>{"date"=>"2024-02-22", "type"=>"ESTIMATED"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-01", "completionDateStruct"=>{"date"=>"2028-10-30", "type"=>"ESTIMATED"}, "lastUpdateSubmitDate"=>"2024-02-26", "studyFirstSubmitDate"=>"2024-01-19", "studyFirstSubmitQcDate"=>"2024-01-19", "lastUpdatePostDateStruct"=>{"date"=>"2024-02-28", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-01-29", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2027-10-30", "type"=>"ESTIMATED"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"comparison alpha diversity", "timeFrame"=>"60 months", "description"=>"comparison alpha diversity of the gut microbiota in groups A and B"}], "secondaryOutcomes"=>[{"measure"=>"comparison beta diversity", "timeFrame"=>"60 months", "description"=>"comparison beta diversity of the gut microbiota in groups A and B"}, {"measure"=>"evaluation of the microbiome differential abundance", "timeFrame"=>"60 months", "description"=>"evaluation of the microbiome differential abundance to identify taxa associated"}]}, "oversightModule"=>{"isFdaRegulatedDrug"=>false, "isFdaRegulatedDevice"=>false}, "conditionsModule"=>{"conditions"=>["Lymphedema", "Microbiota"]}, "descriptionModule"=>{"briefSummary"=>"Lymphedema is a chronic and progressive disease of the lymphatic vessels which affects about 300 million people worldwide. Patients may experience recurrent soft tissue infection of the limb affected by lymphedema, in terms of erysipelas, lymphangitis or cellulitis. No previous study has ever investigated the possible role of the gut microbiota in the genesis of acute infectious/inflammatory episodes in these patients. Our hypothesis is that lymphedema patients with recurrent soft tissue infections are characterized by pro-inflammatory changes in the microbiota."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["ADULT", "OLDER_ADULT"], "maximumAge"=>"85 years", "minimumAge"=>"18 years", "samplingMethod"=>"NON_PROBABILITY_SAMPLE", "studyPopulation"=>"A prospective observational cohort study will be conducted on patients with limb lymphedema, clinical stage I, II and III according to the International Society of Lymphology (ISL), followed by the Plastic Surgery Unit of the University Polyclinic A. Gemelli IRCCS. According to the positive or negative history for recurrent soft tissue infectious episodes, patients will be divided into two homogeneous groups for demographic and clinical characteristics (Groups A and B).", "healthyVolunteers"=>false, "eligibilityCriteria"=>"Inclusion Criteria (Group A):\n\n* 18-85 years\n* primary or secondary, upper or lower limb lymphedema, I-II-III stage ISL\n* at least 3 episodes of soft tissue infection in an year, in the last 2 years\n* consent to participate in the study\n\nInclusion Criteria (Group B):\n\n* 18-85 years\n* primary or secondary, upper or lower limb lymphedema, stage I-II-III (ISL)\n* no episodes of soft tissue infection in the last 2 years\n* consent to participate in the study\n\nExclusion Criteria:\n\n* No compliance to perform limb compression and skin hygiene\n* Antibiotic therapy in the last 15 days\n* Diabetes mellitus\n* Immunodeficiency\n* Ongoing neoplastic pathology\n* Taking immunosuppressive drugs\n* Unavailability to follow-up for at least 24 months post-enrollment."}, "identificationModule"=>{"nctId"=>"NCT06228937", "acronym"=>"LymphFM", "briefTitle"=>"Gut Microbiota in Patients With Limb Lymphedema and Recurrent Lymphangitis", "organization"=>{"class"=>"OTHER", "fullName"=>"Fondazione Policlinico Universitario Agostino Gemelli IRCCS"}, "officialTitle"=>"Typing of Gut Microbiota in Patients With Limb Lymphedema and Recurrent Lymphangitis, a Prospective Observational Study", "orgStudyIdInfo"=>{"id"=>"6208"}}, "armsInterventionsModule"=>{"armGroups"=>[{"label"=>"Group A", "description"=>"patients affected by limb lymphedema with recurrent soft tissue infections", "interventionNames"=>["Other: analysis of a sample of stool"]}, {"label"=>"Group B", "description"=>"patients affected by limb lymphedema without recurrent soft tissue infections", "interventionNames"=>["Other: analysis of a sample of stool"]}], "interventions"=>[{"name"=>"analysis of a sample of stool", "type"=>"OTHER", "description"=>"typing of the gut microbiota from a stool sample", "armGroupLabels"=>["Group A", "Group B"]}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"00168", "city"=>"Rome", "status"=>"RECRUITING", "country"=>"Italy", "contacts"=>[{"name"=>"Stefano Gentileschi, Prof.", "role"=>"CONTACT", "email"=>"stefano.gentileschi@policlinicogemelli.it", "phone"=>"+390630151"}, {"name"=>"Anna Amelia Caretto, MD", "role"=>"CONTACT", "email"=>"annaamelia.caretto@guest.policlinicogemelli.it", "phone"=>"+390630151"}], "facility"=>"Fondazione Policlinico Universitario Agostino Gemelli IRCCS", "geoPoint"=>{"lat"=>41.89193, "lon"=>12.51133}}]}, "ipdSharingStatementModule"=>{"ipdSharing"=>"NO"}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"Fondazione Policlinico Universitario Agostino Gemelli IRCCS", "class"=>"OTHER"}, "responsibleParty"=>{"type"=>"SPONSOR"}}}}
