[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100656714":3},{"organization":4,"outcomesModule":7,"designInfo":34,"detailedDescription":33,"studyPopulation":33,"armGroups":40,"interventions":45,"overallOfficials":33,"centralContacts":51,"locations":33,"responsibleParty":57,"collaborators":33,"id":59,"slug":60,"hasResults":61,"nctId":62,"briefTitle":63,"officialTitle":63,"acronym":64,"eligibilityCriteria":65,"healthyVolunteers":61,"sex":66,"minAge":67,"maxAge":33,"enrollmentInfo":68,"targetDuration":33,"studyType":71,"phases":72,"briefSummary":74,"conditions":75,"keywords":77,"overallStatus":79,"whyStopped":33,"lastUpdateSubmitDate":80,"lastUpdatePostDateStruct":81,"startDateStruct":84,"completionDateStruct":86,"leadSponsor":88,"locationsCount":33},{"fullName":5,"class":6},"University Hospital, Grenoble","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":33},[9],{"measure":10,"description":11,"timeFrame":12},"metabolites and biomarkers associated with luspatercept-related asthenia","Plasma biomarkers, including metabolites (energy metabolism, amino acids, lipid mediators), cortisol, iron-metabolism markers, serotonin, inflammatory cytokines, and selected exosomes derived microRNAs, will be explored, and associated with asthenia evaluated using CTCAE v 6.0. and PROs within the first 6 months of treatment with luspatercept. Fatigue will be graded as follows:\n\n* Grade 1: fatigue relieved by rest,\n* Grade 2: fatigue not relieved by rest, limiting instrumental ADL (activities of daily living)\n* Grade 3: fatigue not relieved by rest, limiting self-care ADL","6 months of treatement",[14,18,22,26,30],{"measure":15,"description":16,"timeFrame":17},"Evolution of fatigue between luspatercept initiation and up to 6 months","Fatigue will be assessed over time through different ways:\n\n(i) EORTC QLQ C30 , assessed at baseline, Week6, Week12, Week18, Week24 (ii) pro-CTCAE (fatigue) , assessed weekly (iii) FACIT-F , assessed at baseline, Week6, Week12, Week18, Week24 (iv) AI-assisted evaluation of fatigue (Fidelio - chatbot): Fidelio will estimate the CTCAE grading, as well as the main treatment-related adverse events and their impact on daily life, as reported by patients. This will be collected continuously according to patient use of the chatbot, and reports will be produced on a weekly basis to the coordinator (v) CTCAE fatigue grading, assessed at baseline, Week6, Week12, Week18, Week24.","baseline, Week6, Week12, Week18, Week24",{"measure":19,"description":20,"timeFrame":21},"Metabolites and plasma biomarkers associated with response to luspatercept","Metabolites and plasma biomarkers will be the same as already described for the primary objective from V0 to V 4 (Week0, Week6, Week12, Week24 except Month 4.5). The response to luspatercept will be measured using IWG 2018 criteria","V0 to V 4 (Week0, Week6, Week12, Week24 except Month 4.5)",{"measure":23,"description":24,"timeFrame":25},"CTCAE fatigue grading","CTCAE fatigue grading will be made by the investigator at baseline, Week6, Week12, Week18, Week24 and estimated by the chatbot Fidelio on a continuous basis (with weekly reports until 24 weeks). Investigators will be blinded to chatbot reports in order to limit bias in the estimation of agreement.","baseline, Week6, Week12, Week18, Week24 and weekly by chatbot up to 24 weeks",{"measure":27,"description":28,"timeFrame":29},"Satisfaction questionnaire about the chatbot","Adherence to the chatbot will be evaluated each week as (i) presence\u002Fabsence of a discussion during the week, and (ii) time spent discussing with the chatbot. (iii) A satisfaction questionnaire of the chatbot will be proposed at the end of the trial on a scale from 0 to 10 (and several qualitative questions yes\u002Fno).","Weekly and at the end of the trial up to 24 weeks",{"measure":31,"description":32,"timeFrame":17},"AE and grading according to CTCAE","Patient reported AE and grading according to CTCAE will be collected at each 6 weeks visits",null,{"allocation":35,"interventionModel":36,"interventionModelDescription":33,"primaryPurpose":37,"observationalModel":33,"timePerspective":33,"maskingInfo":38},"NA","SINGLE_GROUP","TREATMENT",{"masking":39,"maskingDescription":33,"whoMasked":33},"NONE",[41],{"label":42,"type":6,"description":33,"interventionNames":43},"LUSPATERCEPT",[44],"Drug: Luspatercept",[46],{"type":47,"name":48,"description":49,"armGroupLabels":50,"otherNames":33},"DRUG","Luspatercept","The main comparisons will consist in exploring differences in biomarkers plasma levels between patients experiencing fatigue after luspatercept initiation, vs those who do not.",[42],[52],{"name":53,"role":54,"phone":55,"phoneExt":33,"email":56},"Sophie Park, Pr","CONTACT","0033476765697","Spark@chu-grenoble.fr",{"type":58,"investigatorFullName":33,"investigatorTitle":33,"investigatorAffiliation":33,"oldNameTitle":33,"oldOrganization":33},"SPONSOR","100656714","phase-4-plasmatic-biomarkers-associated-with-short-term-luspatercept-treatment-of-lower-risk-myelodysplastic-syndromes-mds-patients-100656714",false,"NCT07830004","Plasmatic Biomarkers Associated With Short-term Luspatercept Treatment of Lower Risk Myelodysplastic Syndromes (MDS) Patients","LUSPAMARK","Inclusion criteria:\n\n1. Signed Written Informed Consent\n2. Participants must be ≥ 18 years of age\n3. Type of Participant and Target Disease Characteristics:\n\n   Participant had documented diagnosis of MDS according to World Health Organization (WHO 2022) classification\n4. IPSS-R : very low, low, or intermediate-risk disease\n5. Less than 5% blasts (\\\u003C 5%) (in bone marrow and \\\u003C 1% PB blasts)\n6. Performance status: Eastern (ECOG) score of 0, 1, or 2\n7. Anemic patients with Hb ≤10g\u002FdL\n8. First line therapy by luspatercept for lower risk MDS RS+ and MDS-RS- patients\n9. Or Second line therapy by luspatercept for MDS-RS+ refractory or intolerant to prior ESA treatment, as defined by any one of the following:\n\n   * Refractory to prior ESA treatment: documentation of nonresponse or response that was no longer maintained to prior ESA-containing regimen, either as a single agent or in combination (eg, with G-CSF).\n   * Intolerant to prior ESA treatment: Documentation of discontinuation of prior ESA-containing regimen, either as a single agent or in combination (eg, with G-CSF), at any time after introduction due to intolerance or an AE\n10. Patient or his entourage having a smartphone to load the application for Fidelio ( the chatbot)\n11. Affiliated to SS\n\nExclusion critéria:\n\n1. Higher risk MDS, del 5q syndrome, MDS-RS-T, MD- CMML\n2. Participant which has known clinically significant anaemia due to iron, vitamin B12, or folate deficiencies, iron deficiency anaemia or autoimmune haemolytic anaemia\n3. Prior allogeneic or autologous stem cell transplant\n4. Use of any of the following within 2-weeks prior to treatment:\n\n   Anticancer cytotoxic chemotherapeutic agent or treatment Any investigational agents within 30 days\n5. Pregnancy\n6. Psychiatric contraindications\n7. Protected people according to articles L1121-5 à L1121-8 of CSP","ALL","18 Years",{"count":69,"type":70},150,"ESTIMATED","INTERVENTIONAL",[73],"PHASE4","Our project aims to identify metabolites and biomarkers associated with luspatercept-related asthenia in a prospective French study of low-risk MDS patients treated per EMA guidelines.\n\nThis is a prospective cohort of patients with MDS treated with luspatercept. The main comparisons will consist in exploring differences in biomarkers plasma levels between patients experiencing fatigue after luspatercept initiation, vs those who do not.",[76],"Myelodysplasia",[78],"fatigue evaluation under LUSPATERCEPT","NOT_YET_RECRUITING","2026-09-14",{"date":82,"type":83},"2026-09-21","ACTUAL",{"date":85,"type":70},"2026-11",{"date":87,"type":70},"2031-11",{"name":5,"class":6}]