[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"clonal-hematopoiesis-of-indeterminate-potential\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:clonal-hematopoiesis-of-indeterminate-potential":25},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,9,0,[8,48,74,103,115,140,179,211,243],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":15,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":23,"conditions":24,"keywords":31,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":47},"100053329","pre-malignant-states-to-hematologic-malignancies-in-firefighters-100053329",false,"NCT06870760","Pre-malignant States to Hematologic Malignancies in Firefighters","Inclusion Criteria:\n\n1. Written informed consent and HIPAA authorization for release of personal health information.\n2. Age ≥ 40-49 years at the time of consent (self-reported)\n3. Ability of the participant to understand and comply with study procedures for the entire length of the study\n4. Currently employed by Charlotte Fire Department (CFD) with at least 5 years on-the -job experience (self-reported)\n\nExclusion Criteria:\n\nAnyone with a current diagnosis of a hematologic malignancy will be excluded.",true,"ALL","40 Years","49 Years",{"count":20,"type":21},300,"ESTIMATED","OBSERVATIONAL","The purpose of the study is to evaluate if firefighter exposure to hazardous compounds will increase the incidence of premalignant hematological states which subsequently increases the risk of the development of hematologic malignancies, and potentially other pathophysiological consequences.",[25,26,27,28,29,30],"Clonal Hematopoiesis of Indeterminate Potential","Monoclonal Gammopathy","Non Hodgkin Lymphoma","Leukemia","Multiple Myeloma","Plasma Cell Disorder",[32,33,34],"Firefighters","CHIP","MGUS","RECRUITING","2026-07-10",{"date":38,"type":39},"2026-07-13","ACTUAL",{"date":41,"type":39},"2026-06-23",{"date":43,"type":21},"2027-04",{"name":45,"class":46},"Wake Forest University Health Sciences","OTHER",1,{"id":49,"slug":50,"hasResults":11,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":4,"eligibilityCriteria":54,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":55,"enrollmentInfo":56,"targetDuration":4,"studyType":58,"phases":59,"briefSummary":61,"conditions":62,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":68,"completionDateStruct":70,"leadSponsor":72,"locationsCount":47},"100620849","phase-4-precision-colchicine-intervention-to-suppress-atherosclerosis-in-tet2-clonal-hematopoiesis-100620849","NCT07362966","Precision Colchicine Intervention to Suppress Atherosclerosis in TET2 Clonal Hematopoiesis","Precision Colchicine Intervention to Suppress Atherosclerosis in TET2 Clonal Hematopoiesis : a Pilot Clinical Trial (PRECISE)","Inclusion Criteria:\n\n1. Age 40-85 years;\n2. Patients with recent hospitalization for documented ACS (the index event occurring 30-90 days before randomization) and meeting all of the following:\n\n   1. During the index hospitalization, patients underwent either PCI or diagnostic coronary angiography alone,\n   2. At least one non-culprit coronary lesion with 30%-70% diameter stenosis by visual estimation on coronary angiography,\n   3. Clinically stable throughout the screening period,\n   4. Receiving standard of care therapy for ACS in accordance with national guidelines,\n   5. Peripheral blood DNA available for targeted sequencing, with results demonstrating either TET2-CHIP or no CHIP-associated variants;\n3. Written informed consent.\n\nExclusion Criteria:\n\n1. Prior coronary artery bypass grafting (CABG) before documented ACS;\n2. Other clinically significant cardiovascular diseases, including moderate-to-severe valvular heart disease (moderate or severe), heart failure (NYHA class III-IV), or atrial fibrillation;\n3. Non-culprit coronary anatomy (e.g., marked tortuosity, bifurcation lesions, or small vessels \\\u003C1.5 mm in diameter) deemed to preclude plaque assessment by CCTA;\n4. Planned PCI or CABG;\n5. Abnormal liver function (ALT \\>3 times the upper limit of normal range) at randomization;\n6. Abnormal renal function (serum creatinine \\>1.5 times the upper limit of normal range or estimated eGFR \\\u003C45 mL\u002Fmin\u002F1.73 m²) at randomization;\n7. Hematologic abnormalities: anemia (hemoglobin \\\u003C100g\u002FL), thrombocytopenia (platelet count \\\u003C100×109\u002FL) or leukopenia (white blood cell \\\u003C3×109\u002FL) at randomization;\n8. Inflammatory bowel disease (Crohn's or ulcerative colitis) or active diarrhea;\n9. Symptomatic peripheral neuropathy, pre-existing progressive neuromuscular disease or creatine kinase (CK) level \\> 3 times the upper limit of normal range as measured within the past 30 days and determined to be non-transient through repeat testing;\n10. Pregnancy, breastfeeding, or women of childbearing potential who are not using an effective method of contraception;\n11. Any contraindication, known allergy or intolerance to colchicine;\n12. Colchicine use within 30 days prior to randomization, or planned colchicine therapy for other indications;\n13. Current or planned use of any of cyclosporine, verapamil, HIV protease inhibitors, azole antifungals, or macrolide antibiotics;\n14. Existing or planned treatment with other anti-inflammatory or immunosuppressive drugs;\n15. History of malignancy (hematologic or solid-tumor);\n16. History of transplantation (hematopoietic stem cell or solid-organ);\n17. Significant radiation exposure (≥40 mSv) within the past 12 months;\n18. Known hypersensitivity to iodinated contrast media or uncontrolled active hyperthyroidism;\n19. Current enrollment in another clinical trial;\n20. A predicted life expectancy \\\u003C 1 year;\n21. Any other circumstances in which the investigator judges that the patient is not suitable to participate in the clinical trial.","85 Years",{"count":57,"type":21},120,"INTERVENTIONAL",[60],"PHASE4","This study aims to investigate whether TET2-associated clonal hematopoiesis of indeterminate potential (TET2-CHIP) can serve as a biomarker to guide precision use of colchicine in a population of clinically stable post-ACS patients receiving standard of care (SoC) therapy. Specifically, we will evaluate whether TET2-CHIP status predicts a differential response to colchicine. As a pilot study, it also aims to provide detailed data supporting design of further trial, such as sample size calculating, endpoint optimizing, etc.",[63,64,25],"Colchicine","Coronary Atherosclerosis Management","2026-06-28",{"date":67,"type":39},"2026-06-30",{"date":69,"type":39},"2026-06-08",{"date":71,"type":21},"2027-12-01",{"name":73,"class":46},"Shenyang Northern Hospital",{"id":75,"slug":76,"hasResults":11,"nctId":77,"briefTitle":78,"officialTitle":79,"acronym":4,"eligibilityCriteria":80,"healthyVolunteers":11,"sex":16,"minAge":81,"maxAge":82,"enrollmentInfo":83,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":85,"conditions":86,"keywords":88,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":93,"lastUpdatePostDateStruct":94,"startDateStruct":96,"completionDateStruct":98,"leadSponsor":100,"locationsCount":47},"100370367","chipccus-natural-history-protocol-100370367","NCT04102423","CHIP\u002FCCUS Natural History Protocol","Investigation of the Natural Progression of Clonal Hematopoiesis of Indeterminate Potential and Clonal Cytopenia of Undetermined Significance.","* Participants with Clonal Hematopoiesis of Indeterminate Significance (CHIP):\n\nINCLUSION CRITERIA:\n\n* Greater than or equal to 18 years of age\n* Willingness and capacity to provide written informed consent\n* Presence of a somatic pathogenic variant associated with hematological malignancy\n* Variant allele fraction of greater than or equal to 2% in at least one identified somatic pathogenic variant\n\nEXCLUSION CRITERIA:\n\n* Known diagnosis of a hematological malignancy or bone marrow failure syndrome (excluding MGUS or MBL)\n* Presence of a cytopenia:\n\n  --Hemoglobin, \\\u003C10 g\u002FdL; platelet count, \\\u003C100 X 10\\^9 \u002FL; or absolute neutrophil count, \\\u003C1.5 X 10\\^9 \u002FL\n* Pregnant at the time of recruitment\n\nParticipants with Clonal Cytopenia of Uncertain Significance (CCUS):\n\nINCLUSION CRITERIA:\n\n* Greater than 18 years of age\n* Willingness and capacity to provide written informed consent\n* Presence of a somatic pathogenic variant associated with hematological malignancy without morphological evidence of\n\nmyelodysplasia and without a MDS defining cytogenetic abnormality\n\n* Variant allele fraction of greater than or equal to 2% in at least one identified somatic pathogenic variant\n* Bone marrow aspirate and biopsy excluding hematological malignancy and MDS\n* Presence of a cytopenia for \\>30 days\n\n  * Hemoglobin, \\\u003C10 g\u002FdL; platelet count, \\\u003C100 X10\\^9 \u002FL; or absolute neutrophil count, \\\u003C1.5 X10\\^9 \u002FL\n  * At least 2 CBCs documented in a non-hospitalized patient at least 3 days apart\n\nEXCLUSION CRITERIA:\n\n* Known diagnosis of a hematological malignancy or bone marrow failure syndrome (excluding MGUS or MBL)\n* Morphological evidence of dysplasia on bone marrow aspirate \u002F biopsy 10% dysplastic cells in any hematopoietic lineage\n* Ringed sideroblasts \\>15%\n* Presence of MDS defining cytogenetic abnormality\n\n  * Del(7q)\n  * del(5q)\n  * 17q or t(17p)\n  * Del(13q)\n  * del(11q)\n  * del(12p) or t(12p)\n  * del(9q)\n  * idic(X)(q13)\n  * t(11;16)\n  * t(3;21)\n  * t(1;3)\n  * t(2;11)\n  * inv(3)\u002Ft(3;3)\n* t(6;9)\n\n  --Note: As a sole cytogenetic abnormality in the absence of morphological criteria, gain of chromosome 8, del(20q) and loss of chromosome Y are not considered definitive evidence of MDS.\n* Alternate hematological diagnosis causing cytopenia\n* Pregnant at time of recruitment","18 Years","99 Years",{"count":84,"type":21},306,"Background:\n\nClonal Hematopoiesis of Indeterminate Potential (CHIP) is a change in a person s DNA that can increase a person s risk of developing blood cancers or cardiovascular disease. CHIP occurs mostly occurs in older people. Clonal cytopenia of undetermined significance (CCUS) occurs when one or more blood cell types is lower than it should be and is associated with a change in their DNA. Researchers want to learn more about how CHIP and CCUS progress.\n\nObjective:\n\nTo examine the natural history of people in a study of CHIP and CCUS to (1) verify the association of myeloid somatic mutations with atherosclerosis and blood cancers, and (2) find new potential clinical associations.\n\nEligibility:\n\nAdults 18 and older with CHIP with a somatic pathogenic variant associated with blood cancers. Adults with CCUS are also needed.\n\nDesign:\n\nPotential participants will be screened with gene testing. For this, they will give a blood sample. They will also be enrolled in NHLBI screening protocol #97-H-0041. Those who pass this screening will visit the NIH Clinical Center for more screening tests. For this, they will give a blood sample. They will have a physical exam. They will give their medical history. They may give a urine sample. Those with CCUS will have bone marrow taken.\n\nEligible participants will give blood and urine samples. Their heart activity will be monitored and tested. The arteries in their neck will be assessed using ultrasound. They will have liver and heart scans. They will have a bone mineral density scan. They will have lung function tests. They will have the inside of their cheek swabbed or have a skin punch biopsy. They will have the option to have advanced scans done of their heart and full body but this is not required.\n\nParticipants will have yearly follow-up visits for 10 years. They will repeat the above procedures every 1-3 years depending on the procedure.",[25,87],"Clonal Cytopenia of Undetermined Significance",[89,90,91,92],"Cytopenia","Myelodysplastic Syndrome","Somatic Mutations","Natural History","2026-06-17",{"date":95,"type":39},"2026-06-18",{"date":97,"type":39},"2020-03-03",{"date":99,"type":21},"2033-09-15",{"name":101,"class":102},"National Heart, Lung, and Blood Institute (NHLBI)","NIH",{"id":104,"slug":4,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":15,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":105,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":23,"conditions":106,"keywords":107,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":108,"lastUpdatePostDateStruct":109,"startDateStruct":111,"completionDateStruct":113,"leadSponsor":114,"locationsCount":47},"100583010",{"count":20,"type":21},[25,26,27,28,29,30],[32,33,34],"2026-04-13",{"date":110,"type":39},"2026-04-16",{"date":112,"type":21},"2026-06",{"date":43,"type":21},{"name":45,"class":46},{"id":116,"slug":117,"hasResults":11,"nctId":118,"briefTitle":119,"officialTitle":120,"acronym":4,"eligibilityCriteria":121,"healthyVolunteers":11,"sex":16,"minAge":122,"maxAge":4,"enrollmentInfo":123,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":125,"conditions":126,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":131,"lastUpdatePostDateStruct":132,"startDateStruct":134,"completionDateStruct":136,"leadSponsor":138,"locationsCount":47},"100458222","metabolic-profiling-of-hematopoietic-stem-cells-in-clonal-hematopoiesis-chip-100458222","NCT05246813","Metabolic Profiling of Hematopoietic Stem Cells in Clonal Hematopoiesis (CHIP)","Metabolic Profiling of Hematopoietic Stem Cells in Clonal Hematopoiesis (CHIP): a Prospective Observational Study","Inclusion Criteria:\n\n* Age 65 years and older\n\nExclusion Criteria:\n\n* known haematological condition (myelodysplasia, leukemia, cancer)\n* inability to provide written informed consent","55 Years",{"count":124,"type":21},24,"Bone marrow samples will be collected from patients undergoing hip arthroplasty surgery. Blood and bone marrow samples will be used for metabolic profiling and analysis of relevant CHIP mutations. Combined single-cell transcriptomics and mutation-specific single-cell genotyping (biotin-PCR using mutation-targeted primers followed by sequencing) will subsequently be performed. The gene expression profile of wildtype and mutant hematopoietic stem cells will be compared, performing both broad gene set enrichment analysis and targeted analysis of metabolic pathways.",[127,128,129,25,130],"Osteoporosis","Osteoarthritis, Hip","Hip Fractures","Aging","2026-03-24",{"date":133,"type":39},"2026-03-25",{"date":135,"type":39},"2022-02-11",{"date":137,"type":21},"2030-12-31",{"name":139,"class":46},"Imelda Hospital, Bonheiden",{"id":141,"slug":142,"hasResults":11,"nctId":143,"briefTitle":144,"officialTitle":145,"acronym":146,"eligibilityCriteria":147,"healthyVolunteers":11,"sex":16,"minAge":81,"maxAge":4,"enrollmentInfo":148,"targetDuration":150,"studyType":22,"phases":4,"briefSummary":151,"conditions":152,"keywords":167,"overallStatus":169,"whyStopped":4,"lastUpdateSubmitDate":170,"lastUpdatePostDateStruct":171,"startDateStruct":173,"completionDateStruct":175,"leadSponsor":177,"locationsCount":47},"100513772","clonal-hematopoiesis-of-immunological-significance-100513772","NCT05969821","Clonal Hematopoiesis of Immunological Significance","Immuno-inflammatory Manifestations With or Without Clonal Hematopoiesis: Ambispective Cohort Study","CHIS","Inclusion Criteria:\n\n* Age \\>=18 years old;\n* Confirmed dysimmune manifestations: clinical or biological abnormality or systemic disease;\n* Presence or absence of myeloid or lymphoid blood disease according to World Health Organization (WHO) classification\n\nExclusion Criteria:\n\n* Persons benefiting from special protection: adults under guardianship and curatorship;\n* People hospitalized without their consent and not protected by law; persons deprived of liberty;\n* Persons not affiliated to the social security system",{"count":149,"type":21},5000,"10 Years","Ambispective, national, multicenter observational cohort study aimed at characterizing the satellite dysimmune manifestations of clonal hematopoiesis, including Vexas (Vacuoles, E1 enzyme, X-linked, Autoinflammatory and Somatic) syndrome.",[153,154,155,156,157,158,25,159,160,161,162,163,164,165,28,166],"Immune System Diseases","Autoimmune Diseases","Inflammation","Autoinflammatory Diseases","Vexas Syndrome","Hematopoiesis Clonal","Hematologic Diseases","Myelodysplastic-Myeloproliferative Diseases","Leukemia Myelomonocytic Chronic","Myelodysplastic Syndromes","Myeloproliferative Disorders","Lymphoproliferative Disorders","Lymphoma","Monoclonal Gammopathy of Undetermined Significance",[155,156,168,154,25,160,164,166],"Vexas syndrome","NOT_YET_RECRUITING","2026-03-19",{"date":172,"type":39},"2026-03-23",{"date":174,"type":21},"2026-04",{"date":176,"type":21},"2045-09",{"name":178,"class":46},"Assistance Publique - Hôpitaux de Paris",{"id":180,"slug":181,"hasResults":11,"nctId":182,"briefTitle":183,"officialTitle":183,"acronym":4,"eligibilityCriteria":184,"healthyVolunteers":11,"sex":16,"minAge":81,"maxAge":4,"enrollmentInfo":185,"targetDuration":4,"studyType":58,"phases":187,"briefSummary":189,"conditions":190,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":201,"lastUpdatePostDateStruct":202,"startDateStruct":204,"completionDateStruct":206,"leadSponsor":208,"locationsCount":210},"100282586","pre-myeloid-cancer-and-bone-marrow-failure-clinic-study-100282586","NCT02958462","Pre-myeloid Cancer and Bone Marrow Failure Clinic Study","Inclusion Criteria:\n\n* Patients with idiopathic cytopenias of unclear significance (ICUS)\n* Patients with clonal hematopoiesis of indeterminate significance (clonal hematopoiesis of indeterminate potential \\[CHIP\\]), including the recently described CHIP syndrome called VEXAS (vacuoles, E1 ubiquitin ligase, X chromosomal, autoimmune and somatic)\n* Patients with clonal cytopenias of undetermined significance (CCUS)\n* Marrow failure syndromes with myeloid malignancy predisposition - telomere dysfunction, chromosomal breakage disorders\n* Germ line inherited syndromes with risk for malignant transformation - GATA2, CEBPA, ETV-6, RUNX1, JAK2, PF6, etc.\n* Low risk MDS (idiopathic dysplasia of unclear significance)\n* Family member of a patient with one of the above conditions\n* Patient at high risk or suspected of developing one of the above conditions\n\nExclusion Criteria:\n\n* Patients under 18 years of age",{"count":186,"type":21},2000,[188],"NA","This clinical trial tests next generation sequencing (NGS) for the detection of precursor features of pre-myeloid cancers and bone marrow failure syndromes. NGS is a procedure that looks at relevant cancer associated genes and what they do. Finding genetic markers for pre-malignant conditions may help identify patients who are at risk of pre-myeloid cancers and bone marrow failure syndromes and lead to earlier intervention.",[191,192,193,89,194,87,25,195,196,197,198,199,200],"Myeloid Malignancy","Inherited Bone Marrow Failure Syndrome","Clonal Expansion","Bone Marrow Failure Syndrome","Hematologic Neoplasms","Hematopoietic and Lymphatic System Neoplasm","Hereditary Neoplastic Syndrome","Idiopathic Cytopenia of Undetermined Significance","Idiopathic Dysplasia of Uncertain Significance","Low Risk Myelodysplastic Syndrome","2026-02-20",{"date":203,"type":39},"2026-02-23",{"date":205,"type":39},"2017-01-16",{"date":207,"type":21},"2035-09-15",{"name":209,"class":46},"Mayo Clinic",3,{"id":212,"slug":213,"hasResults":11,"nctId":214,"briefTitle":215,"officialTitle":216,"acronym":217,"eligibilityCriteria":218,"healthyVolunteers":11,"sex":16,"minAge":219,"maxAge":220,"enrollmentInfo":221,"targetDuration":4,"studyType":58,"phases":223,"briefSummary":224,"conditions":225,"keywords":229,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":233,"lastUpdatePostDateStruct":234,"startDateStruct":236,"completionDateStruct":238,"leadSponsor":240,"locationsCount":242},"100493900","clonal-hematopoiesis-and-nets-formation-in-venous-thrombosis-clodette-100493900","NCT05711173","Clonal Hematopoiesis and NETs Formation in Venous Thrombosis (CLODETTE)","Role of Clonal Hematopoiesis and NETs Formation in Unusual Venous Thrombosis (CLODETTE)","CLODETTE","Inclusion Criteria:\n\n* Patients (male or female) less than 50 y.o with :\n* Splanchnic venous territory thrombosis or\n* Cerebral venous thrombosis or\n* Venous thrombosis of the upper limb or\n* Pulmonary embolism (1st episode if male, 2nd episode if female) unprovoked or\n* 1 episode of deep vein thrombosis + 1 episode of arterial thrombosis\n\nExclusion Criteria:\n\n* Presence of a major or minor transient venous thrombosis risk factor:\n* Surgery within the last 3 months preceding the qualifying thrombotic episode\n* Lower limb fracture with immobilization \\> 3 days in the last 3 months preceding the qualifying thrombotic episode\n* Presence of estro-progestational contraception\n* Pregnancy\n* Immobilization for acute medical reasons within the last 3 months preceding the qualifying thrombotic episode\n* Air or car travel \\> 6 hours\n* Presence of a major or minor persistent risk factor for venous thrombosis:\n* Presence of active cancer (solid cancer or hematologic malignancy)\n* Chronic inflammatory digestive or joint diseases\n* Ongoing treatment with heparin (low molecular weight heparin (LMWH) or unfractionated heparin (UFH))\n* Presence of an abnormality on the thrombophilia test among the following abnormalities\n* Protein C deficiency\n* Protein S deficiency\n* Anti-thrombin deficiency\n* Heterozygous or homozygous factor II mutation\n* Heterozygous or homozygous factor V mutation\n* Presence of anti-phospholipid syndrome\n* Presence of myeloproliferative neoplasia\n* Presence of paroxysmal nocturnal hemoglobinuria","6 Years","50 Years",{"count":222,"type":21},150,[188],"Thrombo-embolic venous diseases are represented by deep venous thrombosis and\u002For pulmonary embolism. In some patients with repeated thrombosis or occurrence of thrombosis in unusual sites, the etiological workup remains negative, which represents a problem for the management of the anticoagulant treatments. Recently, two factors have been identified as important in the physiopathology of hemostasis and coagulation: the presence of clonal hematopoiesis of indetermined potential (CHIP) and the formation of neutrophil extracellular traps (NETs). In this study, these two factors will be studied in patients with repeated venous thrombosis or thrombosis occurring in unusual site.",[226,227,228,25],"Venous Thromboses","Thromboembolic Disease","Neutrophil Extracellular Trap Formation",[230,231,232],"Thrombosis","Venous thrombosis","Clonal hematopoiesis of indetermined potential","2025-03-20",{"date":235,"type":39},"2025-03-21",{"date":237,"type":39},"2023-03-03",{"date":239,"type":21},"2027-03",{"name":241,"class":46},"University Hospital, Bordeaux",7,{"id":244,"slug":245,"hasResults":11,"nctId":246,"briefTitle":247,"officialTitle":247,"acronym":248,"eligibilityCriteria":249,"healthyVolunteers":15,"sex":16,"minAge":81,"maxAge":4,"enrollmentInfo":250,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":252,"conditions":253,"keywords":258,"overallStatus":169,"whyStopped":4,"lastUpdateSubmitDate":265,"lastUpdatePostDateStruct":266,"startDateStruct":268,"completionDateStruct":270,"leadSponsor":272,"locationsCount":4},"100534841","clonal-hematopoiesis-in-giant-cell-arteritis-100534841","NCT06244069","Clonal Hematopoiesis in Giant Cell Arteritis","CH-GCA","Inclusion Criteria:\n\n* Patients with suspected active GCA entering into a fast-track work-up and healthy matched controls.\n* Capability of providing valid consent to study enrollment.\n* Possibility of performing temporal artery biopsy within three hours from enrollment.\n\nExclusion Criteria:\n\n* Active concurrent viral, fungal or bacterial infections (including active\u002Flatent tuberculosis treated for less than 4 weeks, HIV and Hepatitis B\u002FC virus (HBV\u002FHCV) infections.\n* Concurrent systemic inflammation not attributable to GCA (inflammatory diseases in treatment-free remission are accepted).\n* Use of other immunosuppressive agents in the last 3 months.\n* Use of systemic steroids (any dose in the last week, \\> 15 mg\u002Fdie of prednisone equivalent in the last month).\n* Solid or hematologic malignancies (active or with less than 6 months free of disease or antiblastic chemotherapy (hormone therapy is allowed).\n* Previous solid or hematopoietic stem cell transplantation (corneal transplants are allowed).\n* Any systemic immunosuppressive or steroidal therapy.\n* Chronic renal failure with Glomerular Filtration Rate (GFR) \\\u003C 45 ml\u002Fmin \\*1.73 m2.\n* Moderate-severe liver failure (Child-Pugh B or C), hepatitis in stages of activity.\n* Diabetes mellitus.\n* Heart failure with New York Heart Association score (NYHA) \\>=2.\n* Severe hypoproteinemia\u002Fmalnutrition.\n* Chronic respiratory failure requiring O2 therapy or ventilation therapy at home.\n* Any other condition judged by the local investigator as a contra-indication to eligibility.",{"count":251,"type":21},326,"The goal of this clinical trial is to verify whether CHIP is correlated with the clinical, instrumental, and histological characteristics of GCA, and to characterize the pathogenetic effects of clonal hemopoiesis on vasculitis. The main objective of this study is to verify if clonal hematopoiesis of indeterminate potential (CHIP) affects GCA manifestations, course\u002Fresponse to therapies, and pathogenesis.\n\nPatients who are going to be diagnosed with GCA and for which a fast track is available for a rapid diagnostic work-up including pre-treatment temporal artery biopsy. Patients with CHIP will be identified and characterized by using whole exome sequencing from the peripheral blood samples. The presence and characteristics of CHIP will be correlated with baseline clinical, instrumental, and histologic GCA features.",[254,255,25,256,257],"Giant Cell Arteritis","Temporal Arteritis","Horton Disease","Systemic Vasculitis Primary",[259,260,25,261,262,263,264],"Temporal artery biopsy","Giant cell arteritis","Single cell transcriptomics","Large vessels vasculitis","Horton disease","Whole Exome Sequencing","2024-02-02",{"date":267,"type":39},"2024-02-06",{"date":269,"type":21},"2024-03",{"date":271,"type":21},"2031-03",{"name":273,"class":46},"ASST Fatebenefratelli Sacco"]