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NCT04986657 | RECRUITING | Whole Genome Sequencing

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

Washington University School of Medicine

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).

Condition or disease

Whole Genome Sequencing

Acute Myeloid Leukemia

Myelodysplastic Syndromes

Intervention/treatment

ChromoSeq

Phase

NA

Study Type : INTERVENTIONAL
Estimated Enrollment : 275 participants
Masking : NONE
Primary Purpose : DIAGNOSTIC
Official Title : A Prospective Study of Whole Genome Sequencing (ChromoSeq) as an Adjunct to Conventional Genomic Profiling in AML and MDS
Actual Study Start Date : 2021-09-17
Estimated Primary Completion Date : 2027-12-31
Estimated Study Completion Date : 2027-12-31

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: 1
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
    • Whole Genome Sequencing (ChromoSeq) as an Adjunct to Conventional Genomic Profiling in AML and MDS

    Location Details

    NCT04986657

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    How to Participate

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    Locations

    RECRUITING

    United States, Missouri

    Washington University School of Medicine

    St. Louis, Missouri, United States, 63110