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

Part of paid clinical trials in St Louis, Missouri.

Sponsor
Washington University School of Medicine
Study ID
NCT05434598
Status
Recruiting
Apply to this trial

Conditions

  • Myelodysplastic Syndromes
  • Whole Genome Sequencing

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • ChromoSeq — DEVICE
    Novel, streamlined whole genome sequencing approach

Study Details

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).

Key Dates

Start date
Jul 27, 2022
Status verified
Dec 2025
Primary completion
Jul 31, 2027
Completion
Aug 31, 2027

Study Design

Enrollment
60 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC

Arms

  • 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.
  • No Intervention: Stakeholders (Treating Physicians)
    Stakeholders (treating physicians) will complete surveys/questionnaires

Primary Outcome Measure

Rate of assay success on first attempt between ChromoSeq and conventional cytogenetics as measured by total number of recurrent structural variants identified [ Time Frame: Through completion of all ChromoSeq tests (estimated to be 24 months) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Washington University School of MedicineSt LouisMissouri63110
Meagan A Jacoby, M.D., Ph.D.
[email protected]
314-362-9405
Meagan A Jacoby, M.D., Ph.D. (PRINCIPAL_INVESTIGATOR)
Matthew J Walter, M.D. (SUB_INVESTIGATOR)
David H Spencer, M.D., Ph.D. (SUB_INVESTIGATOR)
Mary C Politi, Ph.D. (SUB_INVESTIGATOR)
Matthew Schuelke (SUB_INVESTIGATOR)

Find similar trials in St Louis, MO

By research site
Washington University School of Medicine· St Louis, MO

Related Studies