Ignite Creation Date:
2026-03-26 @ 3:15 PM
Ignite Modification Date:
2026-06-25 @ 1:16 AM
Study NCT ID:
NCT07313592
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-02-09
First Post:
2025-12-17
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Whole Genome Sequencing (ChromoSeq®) for Acute Lymphoblastic Leukemia (ALL) Patients
Sponsor:
Washington University School of Medicine
Organization:
Study Overview
Official Title:
A Prospective Study of Whole Genome Sequencing (ChromoSeq®) at Diagnosis for Pediatric, Adolescent, and Young Adult Acute Lymphoblastic Leukemia (ALL) Patients
Status:
NOT_YET_RECRUITING
Status Verified Date:
2026-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?: