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Observational Study on Leukemia-Typical Mutations in Cord Blood

This observational study aims to understand how childhood leukemias, like Acute Lymphoblastic Leukemia (ALL) and Acute Myeloid Leukemia (AML), might start even before birth. Researchers will collect banked cord blood samples from children diagnosed with these leukemias. They will then look for specific genetic changes (somatic alterations) in these cord blood samples that are also found in the child's leukemia cells. The goal is to identify the very first cells where these leukemia-causing changes occur, potentially leading to a test for early detection of pre-leukemia in the future. You can participate if you have ALL or AML, are 25 years old or younger, and have stored diagnostic samples available. You will also be asked to complete a questionnaire.

Study design
This is an observational study planning to enroll 300 participants. It is not a treatment study but rather focuses on understanding the origins of leukemia.
What's involved
You would provide consent for researchers to access your banked cord blood samples and complete a questionnaire (on paper, online, or by phone).
Compensation
Not stated in the trial record.
Follow-up
The prevalence of genetic changes will be measured for up to 5 years.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05014165

Backtracking Leukemia-Typical Somatic Mutations in Cord Blood

Recruiting
Not specifiedUp to 25Observational
Children's Oncology Group
~300 participants
Updated 2026-04-08 on ClinicalTrials.gov
What's tested:Cord blood Sample CollectionCase identification and recruitmentQuestionnaire Administration

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Prevalence of patient-specific somatic alterations found in cord blood in each molecularly-defined subtype of leukemia leukemia patients in Project:EveryChild.
Measured over up to 5 years

Conditions

Acute Lymphoblastic Leukemia
Acute Myeloid Leukemia

Explore related trials

Acute Lymphoblastic LeukemiaAcute Myeloid Leukemia

NCT05014165

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • University of Minnesota/Masonic Cancer Center

    Minneapolis, Minnesotastudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Adam de Smith, PhD · STUDY_CHAIR · Beckman Research Institute of the City of Hope
  • Logan Spector, PhD · STUDY_CHAIR · Masonic Cancer Center, University of Minnesota

Who to contact

Adam de Smith, PhD
[email protected]
(626) 218-4913
Email the study team

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Eligibility criteria

Inclusion

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

Exclusion

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.

What this trial measures

  • Prevalence of patient-specific somatic alterations found in cord blood in each molecularly-defined subtype of leukemia leukemia patients in Project:EveryChild.up to 5 years

    Investigate less common cytogenetic subtypes for which the prenatal origins have not yet been investigated.