Whole Genome Sequencing (ChromoSeq) as an Adjunct to Conventional Genomic Profiling in MDS
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: ChromoSeq.
- Who it may be relevant to
- Registry conditions: Whole Genome Sequencing, Myelodysplastic Syndromes. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Prospective Study of Whole Genome Sequencing (ChromoSeq) as an Adjunct to Conventional Genomic Profiling in MDS
Overview
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).
Interventions
- Device ChromoSeq
Novel, streamlined whole genome sequencing approach
Primary outcome measures
- 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)]
- 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)]
- Proportion of failed ChromoSeq assays [Time frame: Through completion of all ChromoSeq tests (estimated to be 24 months)]
Secondary outcome measures (1)
- Stakeholder perceptions of ChromoSeq [Time frame: Through 1 month after generation of ChromoSeq for all patients enrolled (estimated to be 25 months)]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
United States · 1 center
- Washington University School of Medicine — St Louis
Identifiers
NCT: NCT05434598 · 202206077 · UH3CA272904