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 — PROCEDURE
    Undergo blood sample, hair follicle, and saliva collection
  • Bone Marrow Biopsy — PROCEDURE
    Undergo a bone marrow biopsy
  • Punch Biopsy — PROCEDURE
    Undergo a skin punch biopsy
  • Buccal Swab — PROCEDURE
    Undergo a saliva or buccal swab
  • Clinical Evaluation — OTHER
    Undergo clinical assessment
  • Genetic Counseling — OTHER
    Receive genetic counseling
  • Quality-of-Life Assessment — OTHER
    Ancillary studies
  • Electronic Health Record Review — OTHER
    Ancillary 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

Locations (3)

FacilityCityStateZIPSite coordinators
Mayo Clinic in ArizonaScottsdaleArizona85259
Clinical Trials Referral Office
855-776-0015
Yael N. Kusne, M.D., Ph.D. (PRINCIPAL_INVESTIGATOR)
Mayo Clinic in FloridaJacksonvilleFlorida32224-9980
Clinical Trials Referral Office
855-776-0015
James M. Foran, M.D. (PRINCIPAL_INVESTIGATOR)
Mayo Clinic in RochesterRochesterMinnesota55905
Clinical Trials Referral Office
855-776-0015
Mrinal S. Patnaik, MBBS (PRINCIPAL_INVESTIGATOR)

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