RecruitingNot ApplicableNCT02958462

Pre-myeloid Cancer and Bone Marrow Failure Clinic Study


Sponsor

Mayo Clinic

Enrollment

2,000 participants

Start Date

Jan 16, 2017

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 Years

Inclusion Criteria8

  • 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 Criteria1

  • Patients under 18 years of age

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Interventions

PROCEDUREBiospecimen Collection

Undergo blood sample, hair follicle, and saliva collection

PROCEDUREBone Marrow Biopsy

Undergo a bone marrow biopsy

PROCEDUREPunch Biopsy

Undergo a skin punch biopsy

PROCEDUREBuccal Swab

Undergo a saliva or buccal swab

OTHERClinical Evaluation

Undergo clinical assessment

OTHERGenetic Counseling

Receive genetic counseling

OTHERQuality-of-Life Assessment

Ancillary studies

OTHERElectronic Health Record Review

Ancillary studies


Locations(3)

Mayo Clinic in Arizona

Scottsdale, Arizona, United States

Mayo Clinic in Florida

Jacksonville, Florida, United States

Mayo Clinic in Rochester

Rochester, Minnesota, United States

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NCT02958462


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