NCT07780552Toborzás még nem indult

CHIP in Health and Disease

Deconvolution of Colonal Hematopoiesis Associated Inflammation in Health and Disease

Forrás: ClinicalTrials.gov · Utoljára frissítve: 2026. szept. 21.

Rövid összefoglaló (regiszter, angolul)

Clonal hematopoiesis (CH), including clonal hematopoiesis of indeterminate potential (CHIP), is an age-associated condition characterized by the expansion of hematopoietic stem and progenitor cell clones carrying acquired somatic mutations. Although CH is associated with an increased risk of hematologic malignancies, its greater public health impact derives from its strong association with cardiovascular diseases, including coronary artery disease and stroke. Emerging evidence suggests that CH-associated mutations promote chronic inflammatory signaling in myeloid immune cells, thereby contributing to atherosclerosis and adverse cardiovascular remodeling. This observational translational study aims to characterize the biological spectrum of clonal hematopoiesis across different stages of disease risk and manifestation. Using state-of-the-art single-cell and multi-omics approaches, the study will compare inflammatory pathways, immune cell states, and mutation-associated molecular programs among healthy individuals without CH, individuals with high-risk CH, and patients with CH-associated hematologic or cardiovascular disease. The ultimate goal is to identify shared and disease-specific mechanisms linking clonal hematopoiesis to adverse clinical outcomes and to generate insights for future preventive, anti-clonal, and anti-inflammatory therapeutic strategies.

Állapot (regiszter): Toborzás még nem indult
Vizsgálattípus: Megfigyeléses
Résztvevők száma: 120 (tervezett)
Első benyújtás: 2026. aug. 18.
Kezdés: 2026. okt.
Elsődleges befejezés: 2027. márc.
Fő szponzor: VASCage GmbH
Betegségek: Koszorúér-betegség, Mielodiszplasztikus szindróma (MDS)
NCT-szám: NCT07780552

Mit vállalsz

Vizsgálat típusa: Megfigyeléses
Tervezett résztvevők: 120
2026. okt. és az elsődleges befejezés (2027. márc.) között
1 helyszín, 1 országban
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Korábbi kezelés

Treatment with immunosuppressive medication within the previous 4 weeks, including but not limited to systemic corticosteroids, methotrexate, other disease-modifying antirheumatic drugs (DMARDs), colchicine, TNF-α inhibitors, mTOR inhibitors, calcineurin inhibitors, or immunomodulatory antibodies

Más betegség

History of rheumatologic, autoinflammatory, or autoimmune disease

Kiket keres a vizsgálat

Written informed consent has been obtained for participation in the study "Deconvolution of Clonal Hematopoiesis-Associated Inflammation in Health and Disease"; OR
Participant is enrolled in the Inn.Health study and has provided written informed consent; OR
Participant is enrolled in the study "Clonal Hematopoiesis of Indeterminate Potential and Infarct Severity in ST-Elevation Myocardial Infarction" and has provided written informed consent.
- Group A: Control Group (n=20)
Age ≥60 years
No detectable somatic variant identified by peripheral blood next-generation sequencing (NGS)
No history of stroke or myocardial infarction
No surgery within the previous 3 months
No diagnosis of a WHO-defined neoplasm
No cytopenia at study enrollment Group B: Low-Risk Clonal Hematopoiesis Risk Score (CHRS) Group (n=20)
Age ≥60 years
Somatic variant in DNMT3A, TET2, ASXL1, or JAK2 with variant allele frequency (VAF) ≥2% in peripheral blood
No history of stroke or myocardial infarction
No surgery within the previous 3 months
No diagnosis of a WHO-defined neoplasm
No cytopenia at study enrollment
Low-risk CHRS (\<9.5 points) Group C: Intermediate-/High-Risk CHRS Group (n=20)
Age ≥60 years
Somatic variant in DNMT3A, TET2, ASXL1, or JAK2 with VAF ≥2% in peripheral blood
No history of stroke or myocardial infarction
No surgery within the previous 3 months
No diagnosis of a WHO-defined neoplasm
No cytopenia at study enrollment
Intermediate- or high-risk CHRS (\>9.5 points) Group D: Clonal Cytopenia of Undetermined Significance (CCUS) Group (n=20)
Age ≥60 years
Somatic variant in DNMT3A, TET2, ASXL1, or JAK2 with VAF ≥2% in peripheral blood
No history of stroke or myocardial infarction
No surgery within the previous 3 months
No diagnosis of a WHO-defined neoplasm
Untreated, unexplained cytopenia present for ≥4 months
Hemoglobin \<13 g/dL (men) or \<12 g/dL (women), and/or absolute neutrophil count \<1.8 × 10⁹/L, and/or platelet count \<150 × 10⁹/L
No diagnostic criteria for a defined myeloid neoplasm based on bone marrow examination Group E: Cardiovascular Disease Group (n=20)
Age ≥60 years
Somatic variant in DNMT3A, TET2, ASXL1, or JAK2 with VAF ≥2% in peripheral blood
ST-segment elevation myocardial infarction (STEMI) treated with percutaneous coronary intervention (PCI) within the previous 4 months
No history of coronary artery bypass grafting (CABG)
No history of stroke
No cytopenia at study enrollment
No diagnosis of a WHO-defined neoplasm Group F: Low-Risk Myelodysplastic Syndrome (MDS) Group (n=20)
Age ≥60 years
Untreated, newly diagnosed (\<3 months from diagnosis) low-risk myelodysplastic syndrome according to the Revised International Prognostic Scoring System (IPSS-R score \>1.5 to 3.0)
No history of stroke or myocardial infarction

Életkor a regiszterben: 18 év – - · Nem: nők és férfiak · Egészséges önkénteseket is fogad

A teljes feltétellista: ClinicalTrials.gov

Helyszínek (1)

Helyszínek a regiszter sorrendjében. Ha a profilodba mented a városodat, távolság szerint rendeződnek.

Helyszín	Város	Ország	Helyszín állapota
Medical University Innsbruck Ennek a helyszínnek vagy a koordinátora? Erősítsd meg az állapotát	Innsbruck	Ausztria	Ismeretlen állapot

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