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

The Washington University

Status: Enrolling

Conditions: Whole Genome Sequencing; Myelodysplastic Syndromes; Acute Myeloid Leukemia

Treatments: Device: ChromoSeq

Study type: Interventional

Funder types: Other

Identifiers

NCT04986657

202105123

Details and patient eligibility

About

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).

Enrollment: 325 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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325 participants in 2 patient groups

Patients: ChromoSeq

Experimental group

Description:

ChromoSeq will be performed on bone marrow 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.

Treatment:

Device: ChromoSeq

Stakeholders (Treating Physicians)

No Intervention group

Description:

-Stakeholders (treating physicians) will complete surveys/questionnaires. As of protocol amendment 10/31/2023, the stakeholders (treating physicians) will no longer be completing surveys/questionnaires.