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| ID | Type | Description | Link |
|---|---|---|---|
| UH3CA272904 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| American Society of Hematology | OTHER |
| Edward P. Evans Foundation | OTHER |
| National Cancer Institute (NCI) | NIH |
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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 diagnosis of myelodysplastic syndrome (MDS).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients: ChromSeq | Experimental | 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. |
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| Stakeholders (Treating Physicians) | No Intervention | Stakeholders (treating physicians) will complete surveys/questionnaires |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ChromoSeq | Device | Novel, streamlined whole genome sequencing approach |
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| Measure | Description | Time Frame |
|---|---|---|
| Rate of assay success on first attempt between ChromoSeq and conventional cytogenetics as measured by total number of recurrent structural variants identified | -The number of recurrent structural variants detected by ChromoSeq will be compared to those detected by conventional cytogenetics using two non-inferiority tests for dependent samples using non-inferiority margin of 1%. | Through completion of all ChromoSeq tests (estimated to be 24 months) |
| Rate of assay success on first attempt between ChromoSeq and conventional cytogenetics as measured by total number of copy number alterations identified | The number of copy number alterations detected by ChromoSeq will be compared to those detected by conventional cytogenetics using two non-inferiority tests for dependent samples using non-inferiority margin of 1%. | Through completion of all ChromoSeq tests (estimated to be 24 months) |
| Proportion of failed ChromoSeq assays |
| Through completion of all ChromoSeq tests (estimated to be 24 months) |
| Measure | Description | Time Frame |
|---|---|---|
| Stakeholder perceptions of ChromoSeq |
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Inclusion Criteria Patient:
Note: Patients who have received transfusional support, erythropoietin-stimulating agents, growth factor support, or luspatercept are eligible.
At least 18 years of age.
-Able to understand and willing to sign an IRB approved written informed consent document.
Inclusion Criteria Physician:
Exclusion Criteria Patient:
-Younger than 18 years of age
Exclusion Criteria Physician
-Does not treat patients at Washington University School of Medicine
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Meagan A Jacoby, M.D., Ph.D. | Contact | 314-362-9405 | mjacoby@wustl.edu |
| Name | Affiliation | Role |
|---|---|---|
| Meagan A 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 |
|---|---|
| D009190 | Myelodysplastic Syndromes |
| ID | Term |
|---|---|
| D001855 | Bone Marrow Diseases |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| Through 1 month after generation of ChromoSeq for all patients enrolled (estimated to be 25 months) |