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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Acute Lymphoblastic Leukemia
• Intervention / Treatment: Device: ChromoSeq® assay testing

• Study Type: Observational
• Enrollment (Estimated): 60

Contacts and Locations

• Study Contact: Name: Margaret Ferris, MD, PhD; Phone Number: 314-454-6018; Email: youngm@wustl.edu

Study Locations

• United States
  • Missouri
    • St Louis, Missouri, United States, 63110
      • Washington University School of Medicine/St. Louis Children's Hospital
      • Contact: Margaret Ferris, MD, PhD; Phone Number: 314-454-6018; Email: youngm@wustl.edu
      • Principal Investigator: Margaret Ferris, MD, PhD
      • Sub-Investigator: Feng Gao, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Child and young adult patients diagnosed with acute lymphoid leukemia (ALL) seen at St. Louis Children's Hospital/Washington University School of Medicine.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Child and Young Adult acute lymphoid leukemia (ALL) patients; At time of initial workup, patients will undergo bone marrow and/or peripheral blood collection for ChromoSeq® (requires 1 mL of peripheral blood or bone marrow aspirate).	Device: ChromoSeq® assay testing; Bone marrow and/or peripheral blood sample will be collected and ChromoSeq® assay testing will be completed.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of success of ChromoSeq®	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.	Time of specimen collection to completion of results (total estimated time is 15 days)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comparison of time-to-results of ChromoSeq® and conventional cytogenetics	The proportion of results return within 15 days and the 95% confidence interval will be calculated.	Time of specimen collection to 15 days after collection (total estimated time is 15 days)
Frequency of mismatch between LDA standard testing and ChromoSeq® defined Ph-like patients.	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.	Time of specimen collection to completion of LDA testing (total estimated time is 15 days)

Collaborators and Investigators

• Sponsor: Washington University School of Medicine
• Collaborators: McDonnell Center
• Investigators: Principal Investigator: Margaret Ferris, MD, PhD, Washington University School of Medicine

Publications and helpful links

Helpful Links

• Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine

Study record dates

Study Major Dates

• Study Start (Estimated): May 31, 2026
• Primary Completion (Estimated): June 15, 2028
• Study Completion (Estimated): June 15, 2028

Study Registration Dates

• First Submitted: December 17, 2025
• First Submitted That Met QC Criteria: December 17, 2025
• First Posted (Actual): January 2, 2026

Study Record Updates

• Last Update Posted (Actual): April 13, 2026
• Last Update Submitted That Met QC Criteria: April 8, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Pediatric; T-ALL; Acute Lymphoblastic Leukemia; B-ALL; Next generation sequencing
• Additional Relevant MeSH Terms: Neoplasms; Immune System Diseases; Neoplasms by Histologic Type; Hematologic Diseases; Lymphatic Diseases; Lymphoproliferative Disorders; Immunoproliferative Disorders; Leukemia, Lymphoid; Leukemia; Hemic and Lymphatic Diseases; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Precursor T-Cell Lymphoblastic Leukemia-Lymphoma
• Other Study ID Numbers: 202512057

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All of the individual participant data collected during the trial, after de-identification.
• IPD Sharing Time Frame: Immediately following publication. No end date.
• IPD Sharing Access Criteria: Data will be uploaded to dbGaP.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes