Mayo Clinic
Mrinal S. Patnaik, M.B.B.S.
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.
Myeloid Malignancy
Inherited Bone Marrow Failure Syndrome
Clonal Expansion
Cytopenia
Bone Marrow Failure Syndrome
Clonal Cytopenia of Undetermined Significance
Clonal Hematopoiesis of Indeterminate Potential
Hematologic Neoplasms
Hematopoietic and Lymphatic System Neoplasm
Hereditary Neoplastic Syndrome
Idiopathic Cytopenia of Undetermined Significance
Idiopathic Dysplasia of Uncertain Significance
Low Risk Myelodysplastic Syndrome
Biospecimen Collection
Bone Marrow Biopsy
Punch Biopsy
Buccal Swab
Clinical Evaluation
Genetic Counseling
Quality-of-Life Assessment
Electronic Health Record Review
NA
PRIMARY OBJECTIVES: 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.
| Study Type : | INTERVENTIONAL |
| Estimated Enrollment : | 2000 participants |
| Masking : | NONE |
| Primary Purpose : | SCREENING |
| Official Title : | Pre-myeloid Cancer and Bone Marrow Failure Clinic Study |
| Actual Study Start Date : | 2017-01-16 |
| Estimated Primary Completion Date : | 2030-09-15 |
| Estimated Study Completion Date : | 2035-09-15 |
Information not available for Arms and Intervention/treatment
| Ages Eligible for Study: | 18 Years |
| Sexes Eligible for Study: | ALL |
| Accepts Healthy Volunteers: |
Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.
RECRUITING
Mayo Clinic in Arizona
Scottsdale, Arizona, United States, 85259
RECRUITING
Mayo Clinic in Florida
Jacksonville, Florida, United States, 32224-9980
RECRUITING
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905