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:
- Idiopathic cytopenias of unclear significance (ICUS).
- Clonal cytopenias of unclear significance (CCUS).
- Clonal hematopoiesis of indeterminate prognosis (CHIP).
- Bone marrow failure syndromes with risk for clonal myeloid transformation.
- 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