Clinical trial · Observational
Whole Genome Sequencing (ChromoSeq®) for Acute Lymphoblastic Leukemia (ALL) Patients
A Prospective Study of Whole Genome Sequencing (ChromoSeq®) at Diagnosis for Pediatric, Adolescent, and Young Adult Acute Lymphoblastic Leukemia (ALL) Patients
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 15, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260915-000001
Why stopped (as posted): Admin review
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Lymphoblastic Leukemia | Acute Lymphoblastic Leukemia | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ChromoSeq® assay testing | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- 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).
- interventionNames
- Device: ChromoSeq® assay testing
Primary outcomes (1)
- measure
- Rate of success of ChromoSeq®
- timeFrame
- Time of specimen collection to completion of results (total estimated time is 15 days)
- description
- 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.
Secondary outcomes (2)
- measure
- Comparison of time-to-results of ChromoSeq® and conventional cytogenetics
Eligibility
Eligibility (as posted)
- Sex
- All
- Maximum age
- 30 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available