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

NCT07313592 | Not Yet Recruiting FDA Device

• 1 other identifier: 202512057
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Acute Lymphoblastic Leukemia

Keywords

Acute Lymphoblastic Leukemia; B-ALL; T-ALL; Next generation sequencing; Pediatric

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Comparison of time-to-results of ChromoSeq® and conventional cytogenetics

  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.

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

Study Arms (1)

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

Interventions

ChromoSeq® assay testing DEVICE

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

Child and Young Adult acute lymphoid leukemia (ALL) patients

Eligibility Criteria

• Age: Up to 30 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• 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.

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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Washington University School of Medicine: lead
• McDonnell Center: collaborator

Study Sites (1)

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

St Louis, Missouri, 63110, United States

Location

Related Links

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

Biospecimen

Retention: SAMPLES WITH DNA

Bone marrow aspirate specimen and/or 1 mL of peripheral blood collection will be collected.

MeSH Terms

Conditions

Precursor Cell Lymphoblastic Leukemia-Lymphoma; Precursor T-Cell Lymphoblastic Leukemia-Lymphoma

Condition Hierarchy (Ancestors)

Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Margaret Ferris, MD, PhD

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Margaret Ferris, MD, PhD

CONTACT

314-454-6018; youngm@wustl.edu

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 17, 2025
• First Posted: January 2, 2026
• Study Start (Estimated): May 31, 2026
• Primary Completion (Estimated): June 15, 2028
• Study Completion (Estimated): June 15, 2028
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Immediately following publication. No end date.
• Access Criteria: Data will be uploaded to dbGaP.

Locations

US (1)