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RecruitingNCT04986657

Whole Genome Sequencing (ChromoSeq) as an Adjunct to Conventional Genomic Profiling in AML and MDS

Trial Parameters

ConditionWhole Genome Sequencing
SponsorWashington University School of Medicine
Study TypeINTERVENTIONAL
PhaseN/A
Enrollment325
SexALL
Min Age18 Years
Max AgeN/A
Start Date2021-09-17
Completion2027-12-31
Interventions
ChromoSeq

Eligibility Fast-Check

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Brief Summary

This is a single institution, prospective study of the whole genome sequencing assay, ChromoSeq. Using prospectively collected patient data, coupled with physician surveys, the investigators seek to determine the feasibility of implementing ChromoSeq in addition to standard genomic testing, for patients with the diagnoses of acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS).

Eligibility Criteria

Inclusion Criteria Patient * Patient with a clinical suspicion for a new diagnosis of AML or MDS for whom the diagnostic molecular testing via the hematologic molecular algorithm (HMA) at BJH is requested or planned to be requested. * Adult patients 18 years or older. * Ability to understand and willingness to sign an IRB approved written informed consent document. Inclusion Criteria Physician * Treating physician at Washington University School of Medicine who directs therapy for individuals with hematologic malignancies. * Able and willing to complete standardized questionnaires about usability, and stakeholder perceptions of ChromoSeq during the ChromoSeq implementation process. Exclusion Criteria Patient * Younger than 18 years of age Exclusion Criteria Physician * Does not treat patients at Washington University School of Medicine

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