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Recruiting NCT04986657

Whole Genome Sequencing (ChromoSeq) as an Adjunct to Conventional Genomic Profiling in AML and MDS

No phase Interventional Whole Genome Sequencing Acute Myeloid Leukemia Myelodysplastic Syndromes

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, Acute Myeloid Leukemia, 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 →

Unsure about the terms? Read our patient guide →

Official title

A Prospective Study of Whole Genome Sequencing (ChromoSeq) as an Adjunct to Conventional Genomic Profiling in AML and 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 diagnoses of acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS).

Interventions

  • Device ChromoSeq
    Novel, streamlined whole genome sequencing approach

Primary outcome measures

  • Sensitivity of ChromoSeq as measured by total number of recurrent structural variants identified [Time frame: Through completion of all ChromoSeq tests (estimated to be 15 months)]
  • Sensitivity of ChromoSeq as measured by total number of copy number alterations identified [Time frame: Through completion of all ChromoSeq tests (estimated to be 15 months)]
  • Sensitivity of ChromoSeq as measured by number of single nucleotide variants identified [Time frame: Through completion of all ChromoSeq tests (estimated to be 15 months)]
  • Sensitivity of ChromoSeq as measured by number of insertion-deletions identified [Time frame: Through completion of all ChromoSeq tests (estimated to be 15 months)]
  • Determine if risk-stratification using ChromoSeq correlates with overall-survival [Time frame: Through completion of follow-up for all patients (estimated to be 63 months)]
  • Determine if risk-stratification using ChromoSeq correlates with event-free survival [Time frame: 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 [Time frame: Through completion of all ChromoSeq tests (estimated to be 15 months)]
  • ChromoSeq turnaround time [Time frame: Through completion of all ChromoSeq tests (estimated to be 15 months)]
  • Proportion of failed ChromoSeq assays [Time frame: Through completion of all ChromoSeq tests (estimated to be 15 months)]
Secondary outcome measures (5)
  • Stakeholder perceptions of ChromoSeq [Time frame: Within 1 month after generation of ChromoSeq (estimated to be 2 months)]
  • Stakeholder perceptions of ChromoSeq as measured by the Acceptability of Intervention Measure [Time frame: When 100 genomes have been sequenced (estimated to be 12 months)]
  • Stakeholder perceptions of ChromoSeq as measured by the Intervention Appropriateness Measure [Time frame: When 100 genomes have been sequenced (estimated to be 12 months)]
  • Stakeholder perceptions of ChromoSeq as measured by the Feasibility of Implementation Measure [Time frame: When 100 genomes have been sequenced (estimated to be 12 months)]
  • Stakeholder perceptions of ChromoSeq as measured by the System Usability Scale [Time frame: When 100 genomes have been sequenced (estimated to be 12 months)]

Eligibility criteria

Inclusion Criteria Patient

  • Patient with a clinical suspicion for a new diagnosis of AML or MDS for whom the diagnostic molecular testing via the hematologic molecular algorithm (HMA) at BJH is requested or planned to be requested.
  • Adult patients 18 years or older.
  • Ability to understand and willingness 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 usability, and stakeholder perceptions of ChromoSeq during the ChromoSeq implementation process.

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: NCT04986657 · 202105123

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗