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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

No Placebo-Only Group

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.

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.

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ through 1 month after generation of chromoseq for all patients enrolled (estimated to be 25 months)

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

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

Primary study objectives

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 study objectives

Stakeholder perceptions of ChromoSeq

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: 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

0 / 2Eligibility criteria met