Backtracking Leukemia-Typical Somatic Mutations in Cord Blood

Recruiting now

Conditions studied: Acute Lymphoblastic Leukemia, Acute Myeloid Leukemia

In brief

A comprehensive mechanistic and epidemiological study to obtain banked cord blood samples from consecutive childhood leukemia patients enrolled in the COG Project:EveryChild (APEC14B1) study. Will attempt to backtrack the initiating genomic alteration identified in the matched diagnostic leukemia sample and molecularly characterize pre-leukemic cells. The ultimate goal of this research is to pinpoint the cell of origin of leukemogenic alterations formed in utero, elucidating the etiology of these initiating mutations (as opposed to frank leukemia), and devising a test for circulating pre-leukemia that can be applied on a population-wide basis.

Key facts

Study ID

NCT05014165

Run by

Children's Oncology Group

People needed

300

Starts

2021-08-25

Expected to finish

2026-09-30

Last updated by the study team

2026-04-08

Who can join

Age: any, up to 25. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• The patient must have a diagnosis of acute lymphoblastic leukemia (ALL) or acute myeloid leukemia (AML).
• Stored diagnostic pre-treatment samples corresponding to the patient's original diagnosis of leukemia must be available for request from either the COG Biopathology Center or a treating institution
• The patient must be enrolled on APEC14B1 with consent to future contact and indicate that cord blood was stored at birth in the APEC14B1 registry intake data.
• The patient must also have been registered with COG by a North American (limited to the U.S. and Canada) member institution.
• ≤ 25 years old at the time of original diagnosis with ALL or AML
• The patient must be able to understand written and spoken English or Spanish
• All patients must provide their consent/assent, as appropriate, and for patients under the age of majority at least one parent or legal guardian must provide consent as well
• All institutional, FDA, and NCI requirements for human studies must be met

You may not qualify if…

• Patients who responded that cord blood was not stored at birth are excluded. Patients without stored diagnostic, pre-treatment leukemia samples at either the COG Biopathology Center or their treating institution are excluded.

Where it is running

• University of Minnesota/Masonic Cancer Center — Minneapolis, Minnesota, United States (enrolling)

Full record on ClinicalTrials.gov

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