Pre-myeloid Cancer and Bone Marrow Failure Clinic Study
NCT ID: NCT02958462
Last Updated: 2025-03-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
2000 participants
INTERVENTIONAL
2017-01-16
2035-09-15
Brief Summary
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Detailed Description
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I. To use genomics and functional translational studies to diagnose, prognosticate and potentially offer therapeutic directives for patients with precursor features of myeloid neoplasms (myelodysplastic syndrome \[MDS\], myeloproliferative neoplasms \[MPN\], MDS/MPN overlap syndrome) and germline predisposition/bone marrow failure states, who do not meet the criteria for the diagnosis of these cancers as of yet.
II. To identify patients with precursor myeloid malignancies and bone marrow failure syndromes.
III. To examine the utility of NGS methods for discovery of targets or pathways involved in precursor features of myeloid cancer and bone marrow failure.
IV. To use clinomics/genomics to better understand pathobiology and risk of disease progression.
V. To help better understand the implications of variants of unknown significance using computational biology and functional studies.
VI. To utilize normal, age and sex matched controls to validate genetic and epigenetic testing carried out under this protocol (essential for accurate data analysis).
VII. To assess frailty in patients with clonal hematopoiesis in order to validate genetic and epigenetic testing completed under this protocol as objective assessments of frailty and aging in comparison to standard of care frailty and geriatric assessments.
OUTLINE:
Participants may undergo blood sample collection, a bone marrow biopsy, a skin punch biopsy, hair follicle collection, a buccal swab, and/or saliva collection for NGS analysis on study. Patients may additionally undergo clinical assessment and may receive genetic counseling on study.
Conditions
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Study Design
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NA
SINGLE_GROUP
SCREENING
NONE
Study Groups
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Screening (biospecimen collection, NGS analysis)
Participants may undergo blood sample collection, a bone marrow biopsy, a skin punch biopsy, hair follicle collection, a buccal swab, and/or saliva collection for NGS analysis on study. Patients may additionally undergo clinical assessment and may receive genetic counseling on study.
Biospecimen Collection
Undergo blood sample, hair follicle, and saliva collection
Bone Marrow Biopsy
Undergo a bone marrow biopsy
Punch Biopsy
Undergo a skin punch biopsy
Buccal Swab
Undergo a saliva or buccal swab
Clinical Evaluation
Undergo clinical assessment
Genetic Counseling
Receive genetic counseling
Quality-of-Life Assessment
Ancillary studies
Electronic Health Record Review
Ancillary studies
Interventions
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Biospecimen Collection
Undergo blood sample, hair follicle, and saliva collection
Bone Marrow Biopsy
Undergo a bone marrow biopsy
Punch Biopsy
Undergo a skin punch biopsy
Buccal Swab
Undergo a saliva or buccal swab
Clinical Evaluation
Undergo clinical assessment
Genetic Counseling
Receive genetic counseling
Quality-of-Life Assessment
Ancillary studies
Electronic Health Record Review
Ancillary studies
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Mayo Clinic
OTHER
Responsible Party
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Mrinal S. Patnaik, M.B.B.S.
Principal Investigator
Principal Investigators
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Mrinal S. Patnaik, MBBS
Role: PRINCIPAL_INVESTIGATOR
Mayo Clinic
Locations
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Mayo Clinic in Arizona
Scottsdale, Arizona, United States
Mayo Clinic in Florida
Jacksonville, Florida, United States
Mayo Clinic in Rochester
Rochester, Minnesota, United States
Countries
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Central Contacts
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Facility Contacts
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Related Links
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Mayo Clinic Clinical Trials
Other Identifiers
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NCI-2022-07824
Identifier Type: REGISTRY
Identifier Source: secondary_id
16-004173
Identifier Type: -
Identifier Source: org_study_id
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