Whole Genome Sequencing (ChromoSeq®) for Acute Lymphoblastic Leukemia (ALL) Patients
Purpose
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.
Condition
- Acute Lymphoblastic Leukemia
Eligibility
- Eligible Ages
- Under 30 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
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.
Study Design
- Phase
- Study Type
- Observational
- Observational Model
- Case-Only
- Time Perspective
- Prospective
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
| 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). |
|
Recruiting Locations
Washington University in St. Louis and nearby locations
St Louis, Missouri 63110
More Details
- NCT ID
- NCT07313592
- Status
- Recruiting
- Sponsor
- Washington University School of Medicine