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

Part of paid clinical trials in St Louis, Missouri.

Sponsor
Washington University School of Medicine
Study ID
NCT07313592
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
N/A - 30 Years
Healthy Volunteers
Not accepted

Study Details

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.

Key Dates

First listed
Jan 2, 2026
Start date
Jun 3, 2026
Status verified
Oct 2026
Primary completion
Jul 15, 2028
Completion
Jul 15, 2028

Study Design

Enrollment
60 participants (estimated)

Arms

  • Arm: 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.

Primary Outcome Measure

Rate of success of ChromoSeq® [ Time Frame: Time of specimen collection to completion of results (total estimated time is 15 days) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Washington University School of Medicine/St. Louis Children's HospitalSt LouisMissouri63110
Margaret Ferris, MD, PhD
[email protected]
314-454-6018
Margaret Ferris, MD, PhD (PRINCIPAL_INVESTIGATOR)
Feng Gao, PhD (SUB_INVESTIGATOR)

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