[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100466209":3},{"organization":4,"armGroups":7,"interventions":10,"overallOfficials":15,"centralContacts":20,"locations":29,"responsibleParty":48,"collaborators":10,"id":50,"slug":51,"hasResults":52,"nctId":53,"briefTitle":54,"officialTitle":54,"acronym":10,"eligibilityCriteria":55,"healthyVolunteers":56,"sex":57,"minAge":58,"maxAge":59,"enrollmentInfo":60,"targetDuration":10,"studyType":63,"phases":10,"briefSummary":64,"conditions":65,"keywords":67,"overallStatus":32,"whyStopped":10,"lastUpdateSubmitDate":75,"lastUpdatePostDateStruct":76,"startDateStruct":79,"completionDateStruct":81,"leadSponsor":83,"locationsCount":84},{"fullName":5,"class":6},"National Institutes of Health Clinical Center (CC)","NIH",[8,12],{"label":9,"type":10,"description":11,"interventionNames":10},"Cohort 1",null,"Participants with myelodysplastic syndromes and associated malignancies",{"label":13,"type":10,"description":14,"interventionNames":10},"Cohort 2","Participants (controls) without MDS or associated malignancies, contributing bone marrow",[16],{"name":17,"affiliation":18,"role":19},"Kathy L McGraw, Ph.D.","National Cancer Institute (NCI)","PRINCIPAL_INVESTIGATOR",[21,26],{"name":22,"role":23,"phone":24,"phoneExt":10,"email":25},"Valentina Bolanos, R.N.","CONTACT","(240) 858-7666","valentina.bolanos@nih.gov",{"name":17,"role":23,"phone":27,"phoneExt":10,"email":28},"(240) 760-7134","kathy.mcgraw@nih.gov",[30],{"facility":31,"status":32,"city":33,"state":34,"zip":35,"country":36,"countryCode":37,"cosmosGeoPoint":38,"geoPoint":43,"contacts":44},"National Institutes of Health Clinical Center","RECRUITING","Bethesda","Maryland","20892","United States","US",{"type":39,"coordinates":40},"Point",[41,42],-77.10026,38.98067,{"lat":42,"lon":41},[45],{"name":46,"role":23,"phone":47,"phoneExt":10,"email":10},"For more information at the NIH Clinical Center contact National Cancer Institute Referral Office","888-624-1937",{"type":49,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100466209","comprehensive-molecular-and-clinical-evaluation-of-pediatric-and-adult-mds-100466209",false,"NCT05350748","Comprehensive Molecular and Clinical Evaluation of Pediatric and Adult MDS","* INCLUSION CRITERIA - MDS Participants\n* Either sex, any age.\n* Histologically or cytologically suspected or confirmed myelodysplastic syndromes (MDS), myelodysplastic syndromes\u002Fmyeloproliferative neoplasms (MDS\u002FMPN), MDS\u002Fmyeloproliferative neoplasm with ringed sideroblasts and thrombocytosis (MDS\u002FMPN-RS-T), myelodysplastic syndromes\u002Fmyeloproliferative neoplasms unclassified (MDS\u002FMPN-U), chronic myelomonocytic leukemia (CMML), atypical chronic myeloid leukemia (aCML), secondary acute myeloid leukemia (sAML) with antecedent MDS or MDS\u002FMPN, or participants who have precursor conditions that are associated with a risk of progression to MDS, including but not limited to clonal hematopoiesis of indeterminate potential (CHIP) and clonal cytopenia of unknown significance (CCUS).\n* Participants may have had any amount of prior therapy and may be receiving MDS-directed therapy at time of enrollment.\n* Participants must have an identified primary oncologist, hematologist or generalist outside of NIH who agrees to manage participant care and any diagnostic findings provided by this study.\n\nINCLUSION CRITERIA - Marrow Control Donor Participants\n\n* Either sex, and must be eligible for marrow donation per NIH Clinical Center requirements.\n* No history of hematological malignancies as listed as inclusion in 'Inclusion Criteria - MDS Participants' or current autoimmune disease.\n* Must be scheduled for bone marrow harvest for clinical application (e.g., marrow donation); or, if being evaluated for malignancy, have a clinical bone marrow aspirate scheduled (e.g., to rule out bone marrow involvement).\n\nINCLUSION CRITERIA - All Participants\n\n* Stated willingness to comply with all study procedures and availability for the duration of the study.\n* Ability of participant or parent\u002Fguardian to understand and the willingness to sign a written consent document.\n\nEXCLUSION CRITERIA - All Participants\n\n-Uncontrolled intercurrent illness, psychiatric illness, or other that would limit compliance with study requirements, or at the investigator s discretion.",true,"ALL","1 Day","120 Years",{"count":61,"type":62},1100,"ESTIMATED","OBSERVATIONAL","Background:\n\nMyelodysplastic syndromes (MDS) occur when the cells that make blood cells are abnormal. There are limited treatment options for MDS. Researchers want to learn more through this natural history study so they can develop better treatments.\n\nObjective:\n\nTo study the natural course of MDS and MDS\u002Fmyeloproliferative neoplasms (MPN) and collect biological samples that can help researchers understand the disease.\n\nEligibility:\n\nPeople with suspected or confirmed MDS or MDS\u002FMPN. Healthy donors are also needed. They can be people who are scheduled to donate bone marrow at NIH for a relative, or they may be providing bone marrow in another study.\n\nDesign:\n\nParticipants will be screened with a medical history.\n\nParticipants will have a physical exam. They will give blood and urine samples. They will discuss their symptoms, medications, and ability to perform their normal activities. They will complete surveys about how they are feeling.\n\nParticipants will have a bone marrow biopsy. A needle will be inserted through a small cut. Bone marrow will be removed. A small piece of bone may be removed.\n\nParticipants may have an optional skin biopsy.\n\nParticipants may give optional saliva and stool samples. They may collect these samples at home and mail them to NIH.\n\nParticipants may undergo optional apheresis. One or two needles or intravenous (IV) lines will be placed in their arm, neck, or groin veins. Blood will be removed. A machine will separate out the white cells. The rest of the blood will be returned to the participant.\n\nParticipants will be contacted for follow-up once a year for up to 20 years.\n\nHealthy donors will have marrow collected for this study during their scheduled procedure with no follow-up.",[66],"Myelodysplastic Syndromes",[68,69,70,71,72,73,74],"Heterogenous Stem Cell Disorders","Gene Mutations","Dysplasia","cytopenias","Malignancies","Acute Myeloid Leukemia","Natural History","2026-06-18",{"date":77,"type":78},"2026-06-22","ACTUAL",{"date":80,"type":78},"2022-08-18",{"date":82,"type":62},"2042-05-01",{"name":18,"class":6},1]