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

NCT ID: NCT07313592

Last Updated: 2026-01-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2026-01-31

Study Completion Date

2028-02-15

Brief Summary

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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.

Detailed Description

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Conditions

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Acute Lymphoblastic Leukemia

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Child and Young Adult acute lymphoid leukemia (ALL) patients

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).

ChromoSeq® assay testing

Intervention Type DEVICE

Bone marrow and/or peripheral blood sample will be collected and ChromoSeq® assay testing will be completed.

Interventions

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ChromoSeq® assay testing

Bone marrow and/or peripheral blood sample will be collected and ChromoSeq® assay testing will be completed.

Intervention Type DEVICE

Eligibility Criteria

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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.
Maximum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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McDonnell Center

UNKNOWN

Sponsor Role collaborator

Washington University School of Medicine

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Margaret Ferris, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Washington University School of Medicine

Locations

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Washington University School of Medicine/St. Louis Children's Hospital

St Louis, Missouri, United States

Site Status

Countries

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United States

Central Contacts

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Margaret Ferris, MD, PhD

Role: CONTACT

314-454-6018

Facility Contacts

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Margaret Ferris, MD, PhD

Role: primary

314-454-6018

Related Links

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http://siteman.wustl.edu

Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine

Other Identifiers

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202512057

Identifier Type: -

Identifier Source: org_study_id

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