Whole Genome Sequencing (ChromoSeq®) for Acute Lymphoblastic Leukemia (ALL) Patients
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: ChromoSeq® assay testing.
- Who it may be relevant to
- Registry conditions: Acute Lymphoblastic Leukemia. Basic parameters: up to 30 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Prospective Study of Whole Genome Sequencing (ChromoSeq®) at Diagnosis for Pediatric, Adolescent, and Young Adult Acute Lymphoblastic Leukemia (ALL) Patients
Overview
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.
Interventions
- Device ChromoSeq® assay testing
Bone marrow and/or peripheral blood sample will be collected and ChromoSeq® assay testing will be completed.
Primary outcome measures
- Rate of success of ChromoSeq® [Time frame: Time of specimen collection to completion of results (total estimated time is 15 days)]
Secondary outcome measures (2)
- 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)]
- 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)]
Eligibility 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-only
Study locations
United States · 1 center
- Washington University School of Medicine/St. Louis Children's Hospital — St Louis
Identifiers
NCT: NCT07313592 · 202512057