RecruitingNCT07313592

Whole Genome Sequencing (ChromoSeq®) for Acute Lymphoblastic Leukemia (ALL) Patients

A Prospective Study of Whole Genome Sequencing (ChromoSeq®) at Diagnosis for Pediatric, Adolescent, and Young Adult Acute Lymphoblastic Leukemia (ALL) Patients


Sponsor

Washington University School of Medicine

Enrollment

60 participants

Start Date

Jun 3, 2026

Study Type

OBSERVATIONAL

Conditions

Summary

This is a prospective specimen collection study evaluating the feasibility of using the ChromoSeq® assay for upfront classification in a real-time clinical setting of pediatric and young adult acute lymphoid leukemia (ALL) patients. Sixty patients will undergo collections of bone marrow and/or peripheral blood for the ChromoSeq® assay at time of initial workup, and the patients will then be followed for clinical outcomes for up to 65 months.


Eligibility

Max Age: 30 Years

Inclusion Criteria5

  • Eligibility Criteria
  • Children and young adult patients (< 30 years of age at time of study enrollment) treated at St. Louis Children's Hospital/Washington University School of Medicine.
  • Suspected diagnosis or suspected relapse of acute lymphoblastic leukemia (ALL), B- or T-cell.
  • Concurrent enrollment on a prospective therapeutic trial is allowed as this protocol makes no recommendations regarding treatment approach.
  • Ability to understand and willingness to sign an IRB approved written informed consent document. All patients and/or their parents or legal guardians must sign an IRB approved written informed consent document.

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Interventions

DEVICEChromoSeq® assay testing

Bone marrow and/or peripheral blood sample will be collected and ChromoSeq® assay testing will be completed.


Locations(1)

Washington University School of Medicine/St. Louis Children's Hospital

St Louis, Missouri, United States

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NCT07313592


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