Official Title
A Prospective Study of Whole Genome Sequencing (ChromoSeq) as an Adjunct to Conventional Genomic Profiling in AML and MDS
Brief Title
Whole Genome Sequencing (ChromoSeq) as an Adjunct to Conventional Genomic Profiling in AML and MDS
Protocol ID
NCT04986657
Lead 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).
Study Period
-
Enrollment Count
325 participants
Eligibility 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
Filters
Whole Genome Sequencing
Acute Myeloid Leukemia
Myelodysplastic Syndromes
NA
RECRUITING
ADULT
OLDER_ADULT