Pre-myeloid Cancer and Bone Marrow Failure Clinic Study
Part of paid clinical trials in Scottsdale, Arizona.
- Sponsor
- Mayo Clinic
- Study ID
- NCT02958462
- Status
- Recruiting
Conditions
- Bone Marrow Failure Syndrome
- Clonal Cytopenia of Undetermined Significance
- Clonal Expansion
- Clonal Hematopoiesis of Indeterminate Potential
- Cytopenia
- Hematologic Neoplasms
- Hematopoietic and Lymphatic System Neoplasm
- Hereditary Neoplastic Syndrome
- Idiopathic Cytopenia of Undetermined Significance
- Idiopathic Dysplasia of Uncertain Significance
- Inherited Bone Marrow Failure Syndrome
- Low Risk Myelodysplastic Syndrome
- Myeloid Malignancy
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Biospecimen Collection — PROCEDUREUndergo blood sample, hair follicle, and saliva collection
- Bone Marrow Biopsy — PROCEDUREUndergo a bone marrow biopsy
- Punch Biopsy — PROCEDUREUndergo a skin punch biopsy
- Buccal Swab — PROCEDUREUndergo a saliva or buccal swab
- Clinical Evaluation — OTHERUndergo clinical assessment
- Genetic Counseling — OTHERReceive genetic counseling
- Quality-of-Life Assessment — OTHERAncillary studies
- Electronic Health Record Review — OTHERAncillary studies
Study Details
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.
Key Dates
- Start date
- Jan 16, 2017
- Status verified
- Mar 2025
- Primary completion
- Sep 15, 2030
- Completion
- Sep 15, 2035
Study Design
- Enrollment
- 2,000 participants (estimated)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- SCREENING
Arms
- Experimental: 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.
Primary Outcome Measure
Occurrence of cytopenias [ Time Frame: Up tof 5 years ]
Central Contacts
- Dani Rud507-284-0228
- Clinical Trials Referral Office855-776-0015
Locations (3)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Mayo Clinic in Arizona | Scottsdale | Arizona | 85259 | Yael N. Kusne, M.D., Ph.D. (PRINCIPAL_INVESTIGATOR) |
| Mayo Clinic in Florida | Jacksonville | Florida | 32224-9980 | James M. Foran, M.D. (PRINCIPAL_INVESTIGATOR) |
| Mayo Clinic in Rochester | Rochester | Minnesota | 55905 | Mrinal S. Patnaik, MBBS (PRINCIPAL_INVESTIGATOR) |
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