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NCT Number: NCT07313592

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

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.

Why the study stopped: Admin review
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Key information

Conditions

Acute Lymphoblastic Leukemia Hematologic Diseases Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Leukemia Leukemia, Lymphoid Lymphatic Diseases Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Precursor Cell Lymphoblastic Leukemia-Lymphoma Precursor T-Cell Lymphoblastic Leukemia-Lymphoma

Age range

Up to 30 year

Sex eligibility

All sexes

Study type

Observational

Primary location

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

St Louis, Missouri, 63110, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ChromoSeq® assay testing

Device

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

Primary outcomes

  1. Rate of success of ChromoSeq®

    Time frame: Time of specimen collection to completion of results (total estimated time is 15 days)

    ChromoSeq® will be successful if the results on the first attempt in a real-time, clinical setting identifies recurrent structural variants and copy number alterations of conventional cytogenetics and karyotype. The success rate and the 95% confidence interval will be calculated.

Secondary outcomes

  1. Comparison of time-to-results of ChromoSeq® and conventional cytogenetics

    Time frame: Time of specimen collection to 15 days after collection (total estimated time is 15 days)

    The proportion of results return within 15 days and the 95% confidence interval will be calculated.

  2. Frequency of mismatch between LDA standard testing and ChromoSeq® defined Ph-like patients.

    Time frame: Time of specimen collection to completion of LDA testing (total estimated time is 15 days)

    The outcome will be measured by determining the correlation of LDA testing on patients with neutral cytogenetics versus LDA testing on patients whose ChromoSeq® results display a Ph-like translocation for validation.

Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Collaborators

  • McDonnell Center

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Jan 2, 2026
Registry last updated
Sep 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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