Whole Genome Sequencing (ChromoSeq) as an Adjunct to Conventional Genomic Profiling in MDS
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ClinicalTrials.gov Identifier: NCT05434598 |
Recruitment Status :
Recruiting
First Posted : June 28, 2022
Last Update Posted : September 7, 2023
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Condition or disease | Intervention/treatment | Phase |
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Whole Genome Sequencing Myelodysplastic Syndromes | Device: ChromoSeq | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 60 participants |
Allocation: | Non-Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Diagnostic |
Official Title: | A Prospective Study of Whole Genome Sequencing (ChromoSeq) as an Adjunct to Conventional Genomic Profiling in MDS |
Actual Study Start Date : | July 27, 2022 |
Estimated Primary Completion Date : | July 31, 2024 |
Estimated Study Completion Date : | August 31, 2024 |
Arm | Intervention/treatment |
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Experimental: Patients: ChromSeq
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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Device: ChromoSeq
Novel, streamlined whole genome sequencing approach |
No Intervention: Stakeholders (Treating Physicians)
Stakeholders (treating physicians) will complete surveys/questionnaires
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- Rate of assay success on first attempt between ChromoSeq and conventional cytogenetics as measured by total number of recurrent structural variants identified [ Time Frame: Through completion of all ChromoSeq tests (estimated to be 24 months) ]-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%.
- Rate of assay success on first attempt between ChromoSeq and conventional cytogenetics as measured by total number of copy number alterations identified [ Time Frame: Through completion of all ChromoSeq tests (estimated to be 24 months) ]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%.
- Proportion of failed ChromoSeq assays [ Time Frame: Through completion of all ChromoSeq tests (estimated to be 24 months) ]
- As compared to failed standard of care genomic profiling assays
- The proportion of first-run failures for ChromoSeq assays will be compared to the proportion of failed standard of care genomic profiling assays using a directional Fisher's exact test.
- Stakeholder perceptions of ChromoSeq [ Time Frame: Through 1 month after generation of ChromoSeq for all patients enrolled (estimated to be 25 months) ]
- Using survey responses from treating physicians obtained from per case standardized questionnaires designed using Consolidated Framework for Implementation Research constructs
- For each case, the corresponding treating physician will be asked to answer a case-based ChromoSeq Implementation Physician Survey. In order to prospectively investigate how the ChromoSeq data was used or could be used by the treating physician for each case, and to evaluate perceptions in real time, the physician will be asked to complete the survey within 1 month of the ChromoSeq and completed conventional genomic profiling results being returned to the chart, whichever is later.
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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria Patient:
- Diagnosis of MDS, or a clinical suspicion for a new diagnosis of MDS, for whom routine diagnostic testing is requested or planned to be requested.
- Seen in the outpatient setting.
- Not been previously treated with disease-modifying therapy (such as lenalidomide or hypomethylating agents).
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:
- Treating physician at Washington University School of Medicine who directs therapy for individuals with hematologic malignancies.
- Able and willing to complete standardized questionnaires about stakeholder perceptions of ChromoSeq during the ChromoSeq implementation process. (Written documentation of informed consent is not required.)
Exclusion Criteria Patient:
-Younger than 18 years of age
Exclusion Criteria Physician
-Does not treat patients at Washington University School of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05434598
Contact: Meagan A Jacoby, M.D., Ph.D. | 314-362-9405 | mjacoby@wustl.edu |
United States, Missouri | |
Washington University School of Medicine | Recruiting |
Saint Louis, Missouri, United States, 63110 | |
Contact: Meagan A Jacoby, M.D., Ph.D. 314-362-9405 mjacoby@wustl.edu | |
Principal Investigator: Meagan A Jacoby, M.D., Ph.D. | |
Sub-Investigator: Matthew J Walter, M.D. | |
Sub-Investigator: David H Spencer, M.D., Ph.D. | |
Sub-Investigator: Mary C Politi, Ph.D. | |
Sub-Investigator: Matthew Schuelke |
Principal Investigator: | Meagan A Jacoby, M.D., Ph.D. | Washington University School of Medicine |
Responsible Party: | Washington University School of Medicine |
ClinicalTrials.gov Identifier: | NCT05434598 |
Other Study ID Numbers: |
202206077 |
First Posted: | June 28, 2022 Key Record Dates |
Last Update Posted: | September 7, 2023 |
Last Verified: | September 2023 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Yes |
Plan Description: | Individual participant data that underlie the results reported in the article, after deidentification (text, tables, figures, and appendices). |
Supporting Materials: |
Study Protocol Statistical Analysis Plan (SAP) Analytic Code |
Time Frame: | Beginning 3 months and ending 5 years following article publication. |
Access Criteria: | 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. |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | Yes |
Device Product Not Approved or Cleared by U.S. FDA: | Yes |
Product Manufactured in and Exported from the U.S.: | No |
Myelodysplastic Syndromes Bone Marrow Diseases Hematologic Diseases |