Hematologic Neoplasms Clinical Trial
Official title:
Pre-myeloid Cancer and Bone Marrow Failure Clinic Study
Verified date | March 2024 |
Source | Mayo Clinic |
Contact | Brittany Burnap |
Phone | 507-293-1764 |
cimpmlresearch[@]mayo.edu | |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Recruiting |
Enrollment | 2000 |
Est. completion date | September 15, 2035 |
Est. primary completion date | September 15, 2030 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Patients with idiopathic cytopenias of unclear significance (ICUS) - 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) - Patients with clonal cytopenias of undetermined significance (CCUS) - Marrow failure syndromes with myeloid malignancy predisposition - telomere dysfunction, chromosomal breakage disorders - Germ line inherited syndromes with risk for malignant transformation - GATA2, CEBPA, ETV-6, RUNX1, JAK2, PF6, etc. - Low risk MDS (idiopathic dysplasia of unclear significance) - Family member of a patient with one of the above conditions - Patient at high risk or suspected of developing one of the above conditions Exclusion Criteria: - Patients under 18 years of age |
Country | Name | City | State |
---|---|---|---|
United States | Mayo Clinic in Florida | Jacksonville | Florida |
United States | Mayo Clinic in Rochester | Rochester | Minnesota |
United States | Mayo Clinic in Arizona | Scottsdale | Arizona |
Lead Sponsor | Collaborator |
---|---|
Mayo Clinic |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Occurrence of cytopenias | Assessed by the number of subjects whose cytopenias are persistent or progressive over the course of the study | Up tof 5 years | |
Secondary | Occurrence of myelodysplastic syndrome (MDS) | Assessed by the number of subjects who have evolved to MDS over the course of the study | Up to 5 years | |
Secondary | Occurrence of acute myeloid leukemia (AML) | Assessed by the number of subjects who have evolved to AML over the course of the study | Up to 5 years |
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