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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

Study 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.Check my eligibility

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.See study design

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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 outcome measures

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

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

Find a Location

Who is running the clinical trial?

Washington University School of MedicineLead Sponsor

1,935 Previous Clinical Trials

2,299,582 Total Patients Enrolled

Meagan Jacoby, M.D., Ph.D.Principal InvestigatorWashington University School of Medicine

5 Previous Clinical Trials

378 Total Patients Enrolled

Media Library

ChromoSeq Clinical Trial Eligibility Overview. Trial Name: NCT04986657 — N/A

Acute Myeloid Leukemia Research Study Groups: Patients: ChromoSeq, Stakeholders (Treating Physicians)

Acute Myeloid Leukemia Clinical Trial 2023: ChromoSeq Highlights & Side Effects. Trial Name: NCT04986657 — N/A

ChromoSeq 2023 Treatment Timeline for Medical Study. Trial Name: NCT04986657 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the magnitude of participants involved in this clinical trial?

"Affirmative. According to the information posted on clinicaltrials.gov, this trial is actively searching for participants and was initially published on September 17th 2021. The research team seeks 225 patients from a single location as part of their study protocol."

Answered by AI

What are the objectives of this experiment?

"The primary metric of this trial, measured over a period lasting 15 months, is the accuracy of ChromoSeq as determined by the total number of recurrent structural variants identified. Secondary outcomes evaluated include participants' perceptions in terms of Acceptability, Feasibility and Appropriateness; these will be assessed at both 100 and 200 genomes via 4-point surveys ranging from complete disagreement to full agreement."

Answered by AI

Are participants still being recruited for this investigation?

"Affirmative. Perusal of clinicaltrials.gov indicates that this study, which is calling for 225 test subjects from a single site and was first shared on September 17th 2021, is actively recruiting participants."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2021. "Whole Genome Sequencing (ChromoSeq) as an Adjunct to Conventional Genomic Profiling in AML and MDS". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04986657.

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