Whole Genome Sequencing (ChromoSeq) as an Adjunct to Conventional Genomic Profiling in MDS
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorWashington University School of Medicine
About this trial
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).
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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).
Treating physician at Washington University School of Medicine who directs therapy for individuals with hematologic malignancies.
Disqualifiers
None
Trial design
Design model
Parallel
Treatments tested in this trial
ChromoSeq
DeviceNovel, streamlined whole genome sequencing approach
Treatment groups
100 Participants
are divided into 3 treatment groupsGroup A: Arm 1 MDS Patients: ChromoSeqExperimental treatment 1 intervention
Group B: Arm 2 MDS Patients: ChromoSeqExperimental treatment 1 intervention
Group C: Stakeholders (Treating Physicians)No intervention 0 interventions
Trial outcomes
Primary outcomes
1
Rate of assay success on first attempt compared 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%.
Time frame
Through completion of all ChromoSeq tests (estimated to be 24 months, patient involvement 1 day)2
Rate of assay success on first attempt compared 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%.
Time frame
Through completion of all ChromoSeq tests (estimated to be 24 months, patient involvement 1 day)3
Proportion of failed ChromoSeq assays
* 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.
Time frame
Through completion of all ChromoSeq tests (estimated to be 24 months, patient involvement 1 day)4
IPSS-M risk score compared between ChromoSeq and conventional standard of care genomic profiling (Arm 2 only)
Time frame
Through completion of all ChromoSeq tests (estimated to be 24 months, patient involvement 1 day)Secondary outcomes
1
Stakeholder perceptions of ChromoSeq
* 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.
Time frame
Through 1 month after generation of ChromoSeq for all patients enrolled (estimated to be 25 months)2
Number and type of recurrent genomic alterations identified compared between 200-250 X ChromoSeq and standard 60-90X ChromoSeq (Arm 2 only)
Time frame
Through completion of all ChromoSeq tests (estimated to be 24 months, patient involvement 1 day)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Washington University School of Medicine
Lead sponsor
American Society of Hematology
Collaborator
Edward P. Evans Foundation
Collaborator
National Cancer Institute (NCI)
Collaborator
Source ClinicalTrials.gov