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.
Study Type
OBSERVATIONAL
Enrollment
60
Bone marrow and/or peripheral blood sample will be collected and ChromoSeq® assay testing will be completed.
Washington University School of Medicine/St. Louis Children's Hospital
St Louis, Missouri, United States
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.
Time frame: Time of specimen collection to completion of results (total estimated time is 15 days)
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.
Time frame: 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.
Time frame: Time of specimen collection to completion of LDA testing (total estimated time is 15 days)
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