Health TrialsbyHealthPanel

Whole Genome Sequencing (ChromoSeq®) for Acute Lymphoblastic Leukemia (ALL) Patients

ConditionAcute Lymphoblastic Leukemia
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeUp to 30
SponsorWashington University School of Medicine

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

None

Trial 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.

Trial design

Design model

Case-only

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

60 Participants
are grouped into 1 trial group
Group A: Child and Young Adult acute lymphoid leukemia (ALL) patients

Trial outcomes

Primary outcomes

1

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)

Secondary outcomes

1

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)
2

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)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Washington University School of Medicine

Lead sponsor

McDonnell Center

Collaborator

Source ClinicalTrials.gov
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