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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients: ChromoSeq | Experimental | 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. |
|
| Stakeholders (Treating Physicians) | No 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ChromoSeq | Device | Novel, streamlined whole genome sequencing approach |
|
| Measure | Description | Time Frame |
|---|---|---|
| Sensitivity of ChromoSeq as measured by total number of recurrent structural variants identified |
| Through completion of all ChromoSeq tests (estimated to be 15 months) |
| Sensitivity of ChromoSeq as measured by total number of copy number alterations identified |
| Through completion of all ChromoSeq tests (estimated to be 15 months) |
| Sensitivity of ChromoSeq as measured by number of single nucleotide variants identified |
|
| Measure | Description | Time Frame |
|---|---|---|
| Stakeholder perceptions of ChromoSeq |
|
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Inclusion Criteria Patient
Inclusion Criteria Physician
Exclusion Criteria Patient
Exclusion Criteria Physician
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Meagan Jacoby, M.D., Ph.D. | Contact | 314-747-8439 | mjacoby@wustl.edu |
| Name | Affiliation | Role |
|---|---|---|
| Meagan Jacoby, M.D., Ph.D. | Washington University School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Washington University School of Medicine | Recruiting | St Louis | Missouri | 63110 | United States |
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| Label | URL |
|---|---|
| Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine | View source |
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Individual participant data that underlie the results reported in the article, after deidentification (text, tables, figures, and appendices).
Beginning 3 months and ending 5 years following article publication.
Researchers who provide a methodologically sound proposal may submit proposals to mjacoby@wustl.edu. To gain access, data requestors will need to sign a data access agreement.
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| ID | Term |
|---|---|
| D015470 | Leukemia, Myeloid, Acute |
| D009190 | Myelodysplastic Syndromes |
| ID | Term |
|---|---|
| D007951 | Leukemia, Myeloid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| Through completion of all ChromoSeq tests (estimated to be 15 months) |
| Sensitivity of ChromoSeq as measured by number of insertion-deletions identified |
| Through completion of all ChromoSeq tests (estimated to be 15 months) |
| Determine if risk-stratification using ChromoSeq correlates with overall-survival |
| Through completion of follow-up for all patients (estimated to be 63 months) |
| Determine if risk-stratification using ChromoSeq correlates with event-free survival |
| Through completion of follow-up for all patients (estimated to be 63 months) |
| Proportion of cases in which ChromoSeq provides new genetic information to the clinician |
| Through completion of all ChromoSeq tests (estimated to be 15 months) |
| ChromoSeq turnaround time | -Measured from time of order requisition (hematologic molecular algorithm from Barnes Jewish Hospital) to return of report to the medical record | Through completion of all ChromoSeq tests (estimated to be 15 months) |
| Proportion of failed ChromoSeq assays |
| Through completion of all ChromoSeq tests (estimated to be 15 months) |
| Within 1 month after generation of ChromoSeq (estimated to be 2 months) |
| Stakeholder perceptions of ChromoSeq as measured by the Acceptability of Intervention Measure |
| When 100 genomes have been sequenced (estimated to be 12 months) |
| Stakeholder perceptions of ChromoSeq as measured by the Intervention Appropriateness Measure |
| When 100 genomes have been sequenced (estimated to be 12 months) |
| Stakeholder perceptions of ChromoSeq as measured by the Feasibility of Implementation Measure | -Will complete survey at the time when 100 genomes have been sequenced. --4 statements with answers ranging from 1=completely disagree to 5=completely agree. | When 100 genomes have been sequenced (estimated to be 12 months) |
| Stakeholder perceptions of ChromoSeq as measured by the System Usability Scale |
| When 100 genomes have been sequenced (estimated to be 12 months) |
| D006402 |
| Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D001855 | Bone Marrow Diseases |