← Back to Search

Whole Genome Sequencing for Acute Myeloid Leukemia and Myelodysplastic Syndrome

N/A

Recruiting

Led By Meagan Jacoby, M.D., Ph.D.

Research Sponsored by Washington University School of Medicine

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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.

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up when 100 genomes have been sequenced (estimated to be 12 months)

Awards & highlights

No Placebo-Only Group

Summary

This trial will study whether a genomic testing assay, ChromoSeq, is feasible to implement in addition to standard genomic testing for patients with acute myeloid leukemia or myelodysplastic syndrome.

Who is the study for?

This trial is for adults over 18 with suspected new acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS), who can fill out questionnaires about ChromoSeq. Physicians involved must be treating hematologic malignancies at Washington University and able to request diagnostic testing.

What is being tested?

The study tests the feasibility of using ChromoSeq, a whole genome sequencing method, alongside standard genomic tests in AML and MDS patients. It aims to understand its practicality through patient data and physician surveys.

What are the potential side effects?

Since this trial involves genetic testing rather than drug treatment, traditional side effects are not applicable. However, there may be indirect consequences such as anxiety or stress from learning about genetic risks.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am suspected to have AML or MDS and will undergo specific blood testing.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ when 100 genomes have been sequenced (estimated to be 12 months)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~when 100 genomes have been sequenced (estimated to be 12 months)

This trial's timeline: 3 weeks for screening, Varies for treatment, and when 100 genomes have been sequenced (estimated to be 12 months) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

ChromoSeq turnaround time

Determine if risk-stratification using ChromoSeq correlates with event-free survival

Determine if risk-stratification using ChromoSeq correlates with overall-survival

+6 more

Secondary study objectives

Stakeholder perceptions of ChromoSeq

Stakeholder perceptions of ChromoSeq as measured by the Acceptability of Intervention Measure

Stakeholder perceptions of ChromoSeq as measured by the Feasibility of Implementation Measure

+2 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Patients: ChromoSeqExperimental Treatment1 Intervention

ChromoSeq will be performed on bone marrow 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.

Group II: Stakeholders (Treating Physicians)Active Control1 Intervention

-Stakeholders (treating physicians) will complete surveys/questionnaires. As of protocol amendment 10/31/2023, the stakeholders (treating physicians) will no longer be completing surveys/questionnaires.

0 / 1Eligibility criteria met