[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100537777":3},{"organization":4,"outcomesModule":7,"designInfo":30,"detailedDescription":29,"studyPopulation":32,"armGroups":29,"interventions":33,"overallOfficials":37,"centralContacts":42,"locations":47,"responsibleParty":64,"collaborators":66,"id":69,"slug":29,"hasResults":70,"nctId":71,"briefTitle":72,"officialTitle":72,"acronym":73,"eligibilityCriteria":74,"healthyVolunteers":70,"sex":75,"minAge":29,"maxAge":29,"enrollmentInfo":76,"targetDuration":79,"studyType":80,"phases":29,"briefSummary":81,"conditions":82,"keywords":29,"overallStatus":50,"whyStopped":29,"lastUpdateSubmitDate":84,"lastUpdatePostDateStruct":85,"startDateStruct":88,"completionDateStruct":90,"leadSponsor":92,"locationsCount":93},{"fullName":5,"class":6},"Fondazione Policlinico Universitario Campus Bio-Medico","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":29},[9],{"measure":10,"description":11,"timeFrame":12},"Improvement in the Toronto Extremity Salvage Score (TESS)","a change in the TESS greater than 7 points","T0 (1 week before surgery) T1 (1 week post-surgery) and T3 (3 months post-surgery)",[14,17,20,23,25,27],{"measure":15,"description":16,"timeFrame":12},"Pain evaluation","Brief Pain Questionnaire",{"measure":18,"description":19,"timeFrame":12},"Motor performance evaluation","Musculoskeletal Tumor Society Rating Scale",{"measure":21,"description":22,"timeFrame":12},"Evaluation of Quality of Life","Quality-of-Life Questionnaire (QLQ)-C30",{"measure":15,"description":24,"timeFrame":12},"Douleur Neuropathique en 4 Questions",{"measure":15,"description":26,"timeFrame":12},"Leeds Assessment of Neuropathic Symptoms and Signs Scale",{"measure":21,"description":28,"timeFrame":12},"Short Form Health Survey 36",null,{"allocation":29,"interventionModel":29,"interventionModelDescription":29,"primaryPurpose":29,"observationalModel":6,"timePerspective":31,"maskingInfo":29},"PROSPECTIVE","Patients candidates for surgery for soft tissue sarcoma and undergoing post-operative rehabilitation treatment.",[34],{"type":6,"name":35,"description":36,"armGroupLabels":29,"otherNames":29},"survey","Quality of life survey and motor performace survey",[38],{"name":39,"affiliation":40,"role":41},"Sergio Valeri","FPU CampusBioMedico","PRINCIPAL_INVESTIGATOR",[43],{"name":39,"role":44,"phone":45,"phoneExt":29,"email":46},"CONTACT","06225411626","s.valeri@policlinicocampus.it",[48],{"facility":49,"status":50,"city":51,"state":29,"zip":52,"country":53,"countryCode":54,"cosmosGeoPoint":55,"geoPoint":60,"contacts":61},"Fondazione Policlinico Campus Biomedico","RECRUITING","Roma","00128","Italy","IT",{"type":56,"coordinates":57},"Point",[58,59],11.10642,44.99364,{"lat":59,"lon":58},[62],{"name":63,"role":44,"phone":45,"phoneExt":29,"email":46},"Sergio Valeri, MD",{"type":41,"investigatorFullName":39,"investigatorTitle":65,"investigatorAffiliation":5,"oldNameTitle":29,"oldOrganization":29},"Principal Investigator",[67],{"name":68,"class":6},"Fondazione Don Carlo Gnocchi Onlus","100537777",false,"NCT06282237","Clinical Evaluation, Motor Performance and Quality of Life in Patients Affected by Soft Tissue Sarcomas, Undergoing Surgical Treatment: Observational Study","1206","Inclusion Criteria:\n\n\\- Adult patients affected by primary localized soft tissue sarcoma, candidate to limb\u002Ftrunk surgery with wide excision or retroperitoneal resection (including resection of the iliopsoas muscle with possible damage to the femoral nerve) with curative intent.\n\nExclusion Criteria:\n\n* Patients with recurrent tumors;\n* patients with metastatic disease;\n* patients with palliative surgery;\n* patients with amputations.","ALL",{"count":77,"type":78},13,"ESTIMATED","6 Months","OBSERVATIONAL","The main aim of the study is evaluate quality of life and motor performance of patients with soft tissue sarcomas undergoing surgical treatment and post-operative rehabilitation treatment.\n\nPrimary objectives:\n\n* Identification of clinical characteristics and motor damage after surgery for soft tissue sarcomas;\n* Impact of perioperative treatments and surgery on the quality of life of patients with soft tissue sarcomas;\n* Impact of post-operative rehabilitation treatment on quality of life and recovery of motor activity The primary endpoint will be the improvement in the Toronto Extremity Salvage Score (TESS) between T1 (post-surgery) and T3 (at the end of rehabilitation treatment).\n\nSecondary endpoints will be:\n\n1\\. the evolution over the various timepoints of the selected rating scales (Toronto Extremity Salvage Score, Musculoskeletal Tumor Society Rating Scale, Numerical Rating Scale, Brief Pain Questionnaire, Douleur Neuropathique en 4 Questions, Leeds Assessment of Neuropathic Symptoms and Signs Scale, European Organization for Research and Treatment of Cancer, Quality-of-Life Questionnaire (QLQ)-C30, Short Form Health Survey 36);\n\n• The change in walking performance before and after the rehabilitation treatment.",[83],"Sarcoma","2024-02-27",{"date":86,"type":87},"2024-02-28","ACTUAL",{"date":89,"type":87},"2023-07-01",{"date":91,"type":78},"2026-07-01",{"name":5,"class":6},1]