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 diagnosis of myelodysplastic syndrome (MDS).

Conditions

Eligibility

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

Inclusion Criteria

Patient: - Diagnosis of MDS, or a clinical suspicion for a new diagnosis of MDS, for whom routine diagnostic testing is requested or planned to be requested. - Seen in the outpatient setting. - Not been previously treated with disease-modifying therapy (such as lenalidomide or hypomethylating agents). Note: Patients who have received transfusional support, erythropoietin-stimulating agents, growth factor support, or luspatercept are eligible. At least 18 years of age. -Able to understand and willing 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 stakeholder perceptions of ChromoSeq during the ChromoSeq implementation process. (Written documentation of informed consent is not required.)

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: ChromSeq
ChromoSeq will be performed on bone marrow or peripheral blood 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

Recruiting Locations

Washington University in St. Louis and nearby locations

Washington University School of Medicine
St Louis, Missouri 63110
Contact:
Meagan A Jacoby, M.D., Ph.D.
314-362-9405
mjacoby@wustl.edu

More Details

NCT ID
NCT05434598
Status
Recruiting
Sponsor
Washington University School of Medicine

Study Contact

Meagan A Jacoby, M.D., Ph.D.
314-362-9405
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.