What this study is
This is a prospective data collection study evaluating the feasibility of using the ChromoSeq® assay for upfront classification in a real-time clinical setting of pediatric and young patients suspected of having ALL. Sixty patients will undergo collections of bone marrow and/or peripheral blood for the ChromoSeq® assay at time of initial workup as part of standard of care, and the patients will then be followed for clinical outcomes for up to 65 months.
Study details
- Official title
- A Prospective Study of Whole Genome Sequencing (ChromoSeq®) at Diagnosis for Pediatric, Adolescent, and Young Adult Acute Lymphoblastic Leukemia (ALL) Patients
- Sponsor
- Washington University School of Medicine
- Conditions
- Acute Lymphoblastic Leukemia
- Enrolling
- 60 people
- Starts
- 2026-06-03
- Est. completion
- 2028-07-15
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age Up to 30 YearsSex ALLHealthy volunteers Not acceptedYou may qualify if
- 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.
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openWashington University School of Medicine/St. Louis Children's Hospital
St Louis, Missouri, United States
- Margaret Ferris, MD, PhD · Contact314-454-6018youngm@wustl.edu
- Margaret Ferris, MD, PhD · Principal investigator
- Feng Gao, PhD · Sub-investigator
Recruiting
Study team
Sponsor
Washington University School of Medicine
Study ID 202512057
Principal investigator
Margaret Ferris, MD, PhD
Washington University School of Medicine
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.