Acute Lymphoblastic LeukemiaNCT07313592
Whole Genome Sequencing (ChromoSeq®) for Acute Lymphoblastic Leukemia (ALL) Patients
An observational study of Acute Lymphoblastic Leukemia, run by Washington University School of Medicine at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages Up to 30 years
- Conditions the study is for
- Acute Lymphoblastic Leukemia
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Jun 2026to 15 Jul 2028
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 30 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Child and young adult patients with suspected diagnosis or suspected relapse 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Washington University School of Medicine/St. Louis Children's Hospital
St Louis, Missouri, 63110
Margaret Ferris, MD, PhD, 314-454-6018, youngm@wustl.edu
Margaret Ferris, MD, PhD
About this study
Official title: A Prospective Study of Whole Genome Sequencing (ChromoSeq®) at Diagnosis for Pediatric, Adolescent, and Young Adult Acute Lymphoblastic Leukemia (ALL) Patients
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.
- Conditions
- Acute Lymphoblastic Leukemia
- Keywords
- Acute Lymphoblastic Leukemia, B-ALL, T-ALL, Next generation sequencing, Pediatric
- Medical subject headings
- Precursor Cell Lymphoblastic Leukemia-Lymphoma, Precursor T-Cell Lymphoblastic Leukemia-Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Child and Young Adult acute lymphoid leukemia (ALL) patients | Data collection will include patient and disease related characteristics such as demographic information, relevant medical history, ALL classification, diagnosis information, treatment, treatment response, recurrence data, and transplant data. Specific clinical data points collected will include ChromoSeq® testing results, minimal residual disease testing results at 8 days into treatment, end of induction (28 days into treatment) and end of consolidation if applicable (~3 months into treatment), and time of any relapses from time of diagnosis. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
The proportion of results return within 15 days and the 95% confidence interval will be calculated.
Measured: 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.
The outcome will be measured by determining the correlation of LDA testing on patients with neutral cytogenetics versus LDA testing on patients whose ChromoSeq® results display a Ph-like translocation for validation.
Measured: Time of specimen collection to completion of LDA testing (total estimated time is 15 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2026
- Study start3 Jun 2026
- Primary completion15 Jul 2028 (estimated)
- Study completion15 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Lymphoblastic LeukemiaStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- McDonnell Center
- Responsible party
- Sponsor
- Investigators
- Margaret Ferris, MD, PhD, Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07313592
- Sponsor's protocol ID
- 202512057
- Status last verified
- Oct 2026
- First submitted
- 17 Dec 2025
- Last updated
- 9 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All of the individual participant data collected during the trial, after de-identification.