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Purpose

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).

Conditions

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
Yes

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

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Non-Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Diagnostic
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Patients: ChromoSeq 		ChromoSeq will be performed on bone marrow DNA from consented patients in parallel with the standard of care cytogenetics, FISH, and the MyeloSeq gene panel obtained from that sample, in a CLIA licensed environment using CLIA-compliant ChromoSeq procedures.
  • Device: ChromoSeq
    Novel, streamlined whole genome sequencing approach
No Intervention
Stakeholders (Treating Physicians) 		-Stakeholders (treating physicians) will complete surveys/questionnaires. As of protocol amendment 10/31/2023, the stakeholders (treating physicians) will no longer be completing surveys/questionnaires.

Recruiting Locations

Washington University in St. Louis and nearby locations

Washington University School of Medicine
St Louis, Missouri 63110
Contact:
Meagan Jacoby, M.D., Ph.D.
314-747-8439
mjacoby@wustl.edu

More Details

NCT ID
NCT04986657
Status
Recruiting
Sponsor
Washington University School of Medicine

Study Contact

Meagan Jacoby, M.D., Ph.D.
314-747-8439
mjacoby@wustl.edu

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.