Whole Genome Sequencing (ChromoSeq®) for Acute Lymphoblastic Leukemia (ALL) Patients
United States60 participantsStarted 2026-06-03
Plain-language 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.
Who can participate
Age range
30 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1What exactly is ChromoSeq® whole genome sequencing, and how might the results from this test change the way my ALL treatment is planned compared to standard genetic testing my care team would already do?
2Since this trial is labeled as Phase NA and appears to be measuring how often ChromoSeq® successfully produces usable results rather than testing a new drug, does participating carry any additional medical risks beyond the usual risks of my ALL treatment?
3If ChromoSeq® finds something unexpected or significant in my genome, how would that information be shared with me and would it directly affect the treatment decisions my care team makes?
4Could I pursue standard ALL treatment right now while still being eligible to participate in this sequencing study, or would joining this trial affect the timing or type of treatment I receive?
5Are there specific subtypes of ALL or patient characteristics that make the ChromoSeq® results more or less likely to be informative, and does my particular diagnosis fit the profile where this testing would be most useful?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Rate of success of ChromoSeq®
Timeframe: Time of specimen collection to completion of results (total estimated time is 15 days)