Acute Lymphoblastic Leukemia
Conditions
Keywords
Acute Lymphoblastic Leukemia, B-ALL, T-ALL, Next generation sequencing, Pediatric
Brief 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.
Interventions
DEVICEChromoSeq® assay testing
Bone marrow and/or peripheral blood sample will be collected and ChromoSeq® assay testing will be completed.
Sponsors
Washington University School of Medicine
McDonnell Center
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
No minimum to 30 Years
Healthy volunteers
No
Inclusion 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of success of ChromoSeq® | Time of specimen collection to completion of results (total estimated time is 15 days) | 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
| Measure | Time frame | Description |
|---|---|---|
| Comparison of time-to-results of ChromoSeq® and conventional cytogenetics | Time of specimen collection to 15 days after collection (total estimated time is 15 days) | The proportion of results return within 15 days and the 95% confidence interval will be calculated. |
| Frequency of mismatch between LDA standard testing and ChromoSeq® defined Ph-like patients. | Time of specimen collection to completion of LDA testing (total estimated time is 15 days) | 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORMargaret Ferris, MD, PhD
Washington University School of Medicine
Outcome results
None listed