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

The Washington University

Status: Not yet enrolling

Conditions: Acute Lymphoblastic Leukemia

Treatments: Device: ChromoSeq® assay testing

Study type: Observational

Funder types: Other

Identifiers

NCT07313592

202512057

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: Under 30 years old

Volunteers: No Healthy Volunteers

Inclusion and 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.

Trial design

60 participants in 1 patient group

Child and Young Adult acute lymphoid leukemia (ALL) patients

Description:

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).

Treatment:

Device: ChromoSeq® assay testing