Clinical trial Recruiting at 1 site Observational Ages Any age to 30

ChromoSeq testing in kids with ALL to help classify at diagnosis

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

Run by Washington University School of Medicine · NCT07313592 · Data updated 2026-11-12

This study tests how well ChromoSeq® genetic sequencing can classify pediatric and young adult patients with suspected ALL using samples collected at initial workup.

Quick facts

Study typeObservational
AgesAny age to 30 Years
SexAll
Enrollment60 (estimated)
SponsorWashington University School of Medicine
Academic / other
Locations1 site (St Louis, Missouri)
StatusRecruiting
StartedJune 3, 2026
Main results expectedJuly 15, 2028
Study endsJuly 15, 2028
Registry record updatedOctober 9, 2026
Trial IDNCT07313592 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Children and young adults under 30 with suspected ALL (B-ALL or T-ALL) at St. Louis Children’s Hospital/Washington University.

Probably not a fit

Patients whose disease does not yield actionable information from ChromoSeq® or who do not undergo the assay will not receive any study-specific benefit.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study collects bone marrow and/or blood samples from up to 60 children and young adults with suspected ALL to try ChromoSeq® for upfront classification in real time. Patients are followed for clinical outcomes for up to about five and a half years. The protocol does not prescribe treatment choices and allows concurrent participation in other therapeutic trials. The aim is to determine the feasibility of using this sequencing assay as part of standard care to guide initial classification of ALL. Enrollment is at St. Louis Children’s Hospital/Washington University in St. Louis.

Why it matters

Potential benefit: If feasible, ChromoSeq® could provide earlier or more precise upfront classification to inform future treatment decisions for pediatric and young adult ALL patients.

How similar studies have gone: Prior studies in leukemia genomics have shown sequencing-based classification can be informative; this study specifically assesses feasibility in a real-world, upfront setting.

Who can join: the full rules

Show full inclusion / exclusion criteria
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.

Where it's running

  • Washington University School of Medicine/St. Louis Children's Hospital
    St Louis, Missouri, United States
    Recruiting

Study contacts

  • Principal investigator: Margaret Ferris, MD, PhD — Washington University School of Medicine
  • Study coordinator: Margaret Ferris, MD, PhD
  • Email: youngm@wustl.edu
  • Phone: 314-454-6018

Similar studies

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.