[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"melanoma-stage-ii\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:melanoma-stage-ii":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,41],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"100608781","explorative-study-on-addition-of-high-fiber-dried-chicory-root-in-patients-with-an-intermediate-to-high-risk-cutaneous-melanoma-100608781",false,"NCT07206017","Explorative Study on Addition of High-fiber Dried Chicory Root in Patients With an Intermediate to High-risk Cutaneous Melanoma.","Measuring Effects of High-fiber Dried Chicory Root on the Gut Microbiota of Patients With an Intermediate to High-risk Cutaneous Melanoma: an Explorative Study","MELFIB","Inclusion Criteria:\n\n* Age ≥18 years;\n* The participant understands the study and can provide written informed consent;\n* The participant received surgical treatment of an intermediate to high-risk cutaneous melanoma (T2a\u002FN1, T2b, T3a, T3b, T4a, T4b, N0 or N+, M0 stadium without evidence of disease);\n* Being able to read and speak Dutch;\n* Willing to come to the UMCG for practical reasons (visiting the study site);\n* Willing to continue their regular lifestyle patterns during the study.\n\nExclusion Criteria:\n\n* Receiving concurrent adjuvant treatment, adjuvant treatment after the study period is allowed.\n* Having a medical history that may impact study outcomes, such as a diagnosis of diabetes mellitus type 2, heart disease, renal disease, autoimmune disease;\n* Any clinically significant or unstable medical disorder involving the gut, including celiac disease, inflammatory bowel disease, short-bowel syndrome or acute\u002Fchronic pancreatitis;\n* Having an ileostomy or colostomy, as this greatly impacts bowel function and gut microbial composition;\n* Use of antibiotics in the 3 months prior participation in the study;\n* Use of prednisolone or other immunosuppressive medication;\n* Use of tube feeding or sib-feeding;\n* Being pregnant or lactating;\n* Participation in another interventional study at the same time;\n* Unable or unwilling to comply to study rules.","ALL","18 Years",{"count":20,"type":21},20,"ESTIMATED","INTERVENTIONAL",[24],"NA","Exploring the effect of supplementation with daily addition of prebiotic dried chicory root (WholeFiberTM) for 6 weeks on fecal SCFA levels, gut microbial composition and immune cell composition in minimal stage II A melanoma patients following surgical treatment.",[27],"Melanoma, Stage II","RECRUITING","2025-09-25",{"date":31,"type":32},"2025-10-03","ACTUAL",{"date":34,"type":32},"2025-03-26",{"date":36,"type":21},"2027-09-14",{"name":38,"class":39},"University Medical Center Groningen","OTHER",1,{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":47,"eligibilityCriteria":48,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":49,"targetDuration":4,"studyType":51,"phases":4,"briefSummary":52,"conditions":53,"keywords":4,"overallStatus":56,"whyStopped":4,"lastUpdateSubmitDate":57,"lastUpdatePostDateStruct":58,"startDateStruct":60,"completionDateStruct":62,"leadSponsor":64,"locationsCount":40},"100576062","clinical-and-ultrasound-incidence-of-rheumatologic-immune-related-adverse-events-in-stage-iib-iv-melanoma-patients-100576062","NCT06780397","Clinical and Ultrasound Incidence of Rheumatologic Immune Related Adverse Events in Stage IIB-IV Melanoma Patients","Monocentric Study on the Clinical and Ultrasound Incidence of Rheumathologic Immune Related Adverse Events in Patients Affected by Stage IIB, IIC, III and IV Melanoma Under Therapy With Immune-checkpoint Inhibitors","Mel-Immuno-Reu","Inclusion Criteria:\n\n* Adult patients affected by stage IIB, IIC, III and IV melanoma who start systemic therapy with immune-checkpoint inhibitors.\n* Signature of the patient consent to the study.\n\nExclusion Criteria:\n\n* Patients aged below 18 years of age.\n* Patients who are unable to express consent to the study.\n* Patients with a diagnosis of chronic joint diseases: inflammatory arthritis, arthrosis, microcrystalline arthritis, septic arthritis etc.\n* Systemic diseases with likely joint involvement (inflammatory bowel disease, etc.)\n* Previous treatments with immune-checkpoint inhibitors or previous adjuvant therapy with immune-checkpoint inhibitors.",{"count":50,"type":21},100,"OBSERVATIONAL","Rheumatologic adverse events are expected to affect between 3% and 7.5% of patients undergoing immunotherapy and are likely to be underdiagnosed.\n\nThe main aim of this observational prospective study is to investigate the clinical and ultrasonographic incidence of rheumathologic immune related adverse events in a cohort of patients affected by stage IIB, IIC, III and IV melanoma undergoing treatment with immune-checkpoint inhibitors.\n\nPatients will:\n\n* receive immune-checkpoint inhibitor therapy, according to disease stage and current National Guidelines.\n* undergo dermatologic visit prior to the start of immune-checkpoint inhibitor therapy and at scheduled follow-ups.\n* undergo rheumatologic visit prior to the start of immune-checkpoint inhibitor therapy and at scheduled follow-ups.\n* receive a quality of life questionnaire (European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 version 3.0) prior to the start of immune-checkpoint inhibitor therapy and at scheduled follow-ups.",[27,54,55],"Melanoma Stage III","Melanoma Stage IV","NOT_YET_RECRUITING","2025-01-13",{"date":59,"type":32},"2025-01-17",{"date":61,"type":21},"2025-02-01",{"date":63,"type":21},"2028-02-01",{"name":65,"class":39},"Fondazione Policlinico Universitario Agostino Gemelli IRCCS"]