NCT04986657 Whole Genome Sequencing (ChromoSeq) as an Adjunct to Conventional Genomic Profiling in AML and MDS
| NCT ID | NCT04986657 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Washington University School of Medicine |
| Condition | Whole Genome Sequencing |
| Study Type | INTERVENTIONAL |
| Enrollment | 325 participants |
| Start Date | 2021-09-17 |
| Primary Completion | 2027-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 325 participants in total. It began in 2021-09-17 with a primary completion date of 2027-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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).
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
Contact & Investigator
Meagan Jacoby, M.D., Ph.D.
PRINCIPAL INVESTIGATOR
Washington University School of Medicine
Frequently Asked Questions
Who can join the NCT04986657 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Whole Genome Sequencing. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04986657 currently recruiting?
Yes, NCT04986657 is actively recruiting participants. Contact the research team at mjacoby@wustl.edu for enrollment information.
Where is the NCT04986657 trial being conducted?
This trial is being conducted at St Louis, United States.
Who is sponsoring the NCT04986657 clinical trial?
NCT04986657 is sponsored by Washington University School of Medicine. The principal investigator is Meagan Jacoby, M.D., Ph.D. at Washington University School of Medicine. The trial plans to enroll 325 participants.