Clinical Trial: Pre-myeloid Cancer and Bone Marrow Failure Clinic Study

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Pre-myeloid Cancer and Bone Marrow Failure Clinic Study

Brief Summary: The use of genomics and functional translational studies is to identify and diagnose patients with precursor features of myeloid neoplasms and inherited bone marrow failure syndromes.

Detailed Summary:

The pre-myeloid cancer and bone marrow failure clinic is an individualized medicine clinic conceptualized for the early detection of myeloid malignancies such as, myelodysplastic syndromes (MDS), myeloproliferative neoplasms (MPN), MDS/MPN overlap syndromes and acute myeloid leukemia (AML). Using next-generation sequencing technologies, clonal hematopoietic stem cell changes can be detected early on in myeloid malignancies. These changes are currently classified as follows:

  1. Idiopathic cytopenias of unclear significance (ICUS).
  2. Clonal cytopenias of unclear significance (CCUS).
  3. Clonal hematopoiesis of indeterminate prognosis (CHIP).
  4. Bone marrow failure syndromes with risk for clonal myeloid transformation.
  5. Familial/Germline syndromes with increased risk for myeloid malignancies.

This clinic blends next-generation sequencing technologies with functional studies to help identify, prognosticate and define management plans; including early intervention strategies, for affected patients.


Sponsor: Mayo Clinic

Current Primary Outcome: Number of subjects whose cytopenias are persistent or progressive over the course of the 5 year study [ Time Frame: Through study completion, an average of 5 years ]

Original Primary Outcome: Same as current

Current Secondary Outcome: Number of subjects who have evolved to myelodspalstic syndrome (MDS) or acute myeloid leukemia (aml) over the course of the five year study [ Time Frame: Through study completion, an average of 5 years ]

Original Secondary Outcome: Same as current

Information By: Mayo Clinic

Dates:
Date Received: November 4, 2016
Date Started: November 2016
Date Completion: January 2023
Last Updated: November 10, 2016
Last Verified: November 2016