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ChromoSeq for Myelodysplastic Syndrome

N/A
Recruiting
Led By Meagan A 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
At least 18 years of age.
Not been previously treated with disease-modifying therapy (such as lenalidomide or hypomethylating agents).
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through 1 month after generation of chromoseq for all patients enrolled (estimated to be 25 months)
Awards & highlights

Study Summary

This trial is testing a new way to sequence the genome of patients with myelodysplastic syndrome to see if it's feasible to use in addition to standard genomic testing.

Who is the study for?
This trial is for adults with Myelodysplastic Syndrome (MDS) or suspected MDS at Washington University School of Medicine. Participants must be willing to complete surveys about ChromoSeq, have not had disease-modifying treatments, and can sign a consent form. Those who've only had supportive treatments like transfusions or growth factors are eligible.Check my eligibility
What is being tested?
The study tests the use of Whole Genome Sequencing (ChromoSeq) alongside standard genomic testing in patients with MDS. It aims to assess how feasible it is to add this new test into routine care by collecting data and physician feedback.See study design
What are the potential side effects?
Since ChromoSeq is a diagnostic procedure rather than a treatment, it does not have direct side effects like medications do. However, there may be indirect consequences such as anxiety from learning new genetic information.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.
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I haven't taken any drugs like lenalidomide for my condition.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through 1 month after generation of chromoseq for all patients enrolled (estimated to be 25 months)
This trial's timeline: 3 weeks for screening, Varies for treatment, and through 1 month after generation of chromoseq for all patients enrolled (estimated to be 25 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
Biological Assay
Rate of assay success on first attempt between ChromoSeq and conventional cytogenetics as measured by total number of copy number alterations identified
Rate of assay success on first attempt between ChromoSeq and conventional cytogenetics as measured by total number of recurrent structural variants identified
Secondary outcome measures
Stakeholder perceptions of ChromoSeq

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Patients: ChromSeqExperimental Treatment1 Intervention
ChromoSeq will be performed on bone marrow or peripheral blood 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

Find a Location

Who is running the clinical trial?

American Society of HematologyOTHER
12 Previous Clinical Trials
20,930 Total Patients Enrolled
Washington University School of MedicineLead Sponsor
1,949 Previous Clinical Trials
2,307,639 Total Patients Enrolled
Meagan A Jacoby, M.D., Ph.D.Principal InvestigatorWashington University School of Medicine

Media Library

ChromoSeq Clinical Trial Eligibility Overview. Trial Name: NCT05434598 — N/A
Myelodysplastic Syndrome Research Study Groups: Patients: ChromSeq, Stakeholders (Treating Physicians)
Myelodysplastic Syndrome Clinical Trial 2023: ChromoSeq Highlights & Side Effects. Trial Name: NCT05434598 — N/A
ChromoSeq 2023 Treatment Timeline for Medical Study. Trial Name: NCT05434598 — N/A
~2 spots leftby Jul 2024
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