[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07057583":3,"trial-entities:NCT07057583":81,"trial-summary:NCT07057583":84},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":21,"study_type":22,"primary_purpose":23,"phases":24,"enrollment_info":25,"interventions":28,"primary_outcomes":35,"secondary_outcomes":40,"sex":41,"minimum_age":42,"maximum_age":23,"healthy_volunteers":43,"eligibility_criteria":44,"std_ages":58,"locations":61,"central_contacts":71,"overall_officials":72,"references":76,"see_also_links":77},"NCT07057583","24-003478","A Study of Carbon 13-based Deep Labelling of Bone Marrow Cells","A Pilot Study of 13Carbon-Based Deep Labeling of Bone Marrow Cells to Map Their Utilization of Extracellular Metabolites","ENROLLING_BY_INVITATION","2027-12-31","2025-12","2025-12-19","2025-02-01","Mayo Clinic","OTHER",false,"This study evaluates a novel laboratory method to study how certain bone marrow cells in the body take up nutrients from their environment.","PRIMARY OBJECTIVE:\n\nI. Evaluate differences in the amount of extracellular uptake of glucose and amino acids (AAs) between pre-malignant clonal plasma cells (cPCs) and polyclonal plasma cells (pPCs).\n\nOUTLINE: This is an observational study. Participants are assigned to 1 of 2 groups.\n\nGROUP I: Patients undergo blood collection and bone marrow aspiration as part of their standard care and have their medical records reviewed on study.\n\nGROUP II: Healthy volunteers undergo blood collection and bone marrow aspiration on study.",[19,20],"Monoclonal Gammopathy of Undetermined Significance (MGUS)","Non-IgM Monoclonal Gammopathy of Undetermined Significance",[],"OBSERVATIONAL",null,[],{"count":26,"type":27},40,"ESTIMATED",[29],{"type":14,"name":30,"description":31,"armGroupLabels":32},"Non-Interventional Study","Non-interventional study",[33,34],"Observational Group I","Observational Group II",[36],{"measure":37,"description":38,"timeFrame":39},"Extracellular uptake of glucose and amino acids (AAs) between pre-malignant clonal plasma cells (cPCs) and polyclonal plasma cells (pPCs)","Assessed by evaluating blood and bone marrow aspirate samples for mean 13Carbon (13C) percentage enrichment of the mass isotopomers of interest of at least 6 (i.e. the difference between a mean 13C percentage enrichment of a particular mass isotopomer is 12% in the MGUS group and 6% in the healthy participant group or vice versa) using a 2-group t-test with a 2-sided significance level of 0.01.","Up to 30 days",[],"ALL","18 Years",true,{"inclusion":45,"exclusion":51,"raw_text":57},[46,47,48,49,50],"All Participants:","At least age 18 years or older","Able to provide informed consent","MGUS Cohort:","International Myeloma Working Group (IMWG) criteria for the diagnosis of non-IgM MGUS",[46,52,53,54,55,56],"Unable to provide consent","Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) \\>1","Prior history of adverse events with conscious sedation","Ongoing use of immunosuppressive medications","All known pregnant and lactating women will be excluded","Inclusion Criteria:\n\n* All Participants:\n\n  * At least age 18 years or older\n  * Able to provide informed consent\n* MGUS Cohort:\n\n  * International Myeloma Working Group (IMWG) criteria for the diagnosis of non-IgM MGUS\n\nExclusion Criteria:\n\n* All Participants:\n\n  * Unable to provide consent\n  * Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) \\>1\n  * Prior history of adverse events with conscious sedation\n  * Ongoing use of immunosuppressive medications\n  * All known pregnant and lactating women will be excluded",[59,60],"ADULT","OLDER_ADULT",[62],{"facility":63,"city":64,"state":65,"zip":66,"country":67,"geoPoint":68},"Mayo Clinic in Rochester","Rochester","Minnesota","55905","United States",{"lat":69,"lon":70},44.02163,-92.4699,[],[73],{"name":74,"affiliation":63,"role":75},"Wilson I. Gonsalves, MD","PRINCIPAL_INVESTIGATOR",[],[78],{"label":79,"url":80},"Mayo Clinic Clinical Trials","https:\u002F\u002Fwww.mayo.edu\u002Fresearch\u002Fclinical-trials",{"nct_id":4,"conditions":82,"biomarkers":83},[20],[],{"nct_id":4,"found":15,"summary":23,"prompt_version":23}]