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

StatusRecruiting
PhaseNot applicable
Started

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Trial flagged as At Risk
Primary endpoint added 3 → 4 primary endpoints
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Record History

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  1. Primary endpoint(s) modified Show 5 more changesShow less
    • Enrollment increased: 60 → 100 participants
    • Trial arms changed: 2 → 3
    • Secondary endpoints: 1 to 2
    • Site contact updated
    • Eligibility criteria expanded, about 5 words
  2. Collaborators: 2 to 3v10
  3. Collaborators: 3 to 2v9
  4. Collaborators: 1 to 3v8
  5. Primary completion date: Jul 31, 2024 to Jul 31, 2027
    • Study completion date: Aug 31, 2024 to Aug 31, 2027
    v7
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  1. Primary completion date: Oct 31, 2023 to Jul 31, 2024
    • Study completion date: Nov 30, 2023 to Aug 31, 2024
    • Secondary endpoints: details revised at 1 of 1 entry
    • Collaborators expanded, about 4 words
    v6
  2. Re-verified, no change to tracked fieldsv5
  3. Trial status: Not Yet Recruiting to Recruitingv4 Show 4 more changesShow less
    • Primary completion date: Nov 30, 2023 to Oct 31, 2023
    • Study completion date: Dec 31, 2023 to Nov 30, 2023
    • Start date changed from estimate of Aug 31, 2022 to Jul 27, 2022
    • Site details revised
  4. 2 versions Re-verified since Jun 28, 2022, no change to tracked fieldsv2-v3
  1. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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).
Trial Details
NCT Number NCT05434598
Lead Sponsor Washington University School of Medicine
Collaborators: American Society of Hematology, Edward P. Evans Foundation, National Cancer Institute (NCI)
Conditions
(from sponsor)		 Whole Genome Sequencing, Myelodysplastic Syndromes
Related terms Myelodysplastic Syndromes
Enrollment 100 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov