Clinical trial Recruiting at 1 site Observational Ages Any age to 25

Investigating genetic changes in cord blood from childhood leukemia patients

Official title: Backtracking Leukemia-Typical Somatic Mutations in Cord Blood

Run by Children's Oncology Group · NCT05014165 · Data updated 2026-11-12

This study is trying to understand the genetic changes in cord blood from children with leukemia to see if it can help find early signs of the disease before it develops.

More Acute Lymphoblastic Leukemia trials

Quick facts

Study typeObservational
AgesAny age to 25 Years
SexAll
Enrollment300 (estimated)
SponsorChildren's Oncology Group
Research network
Locations1 site (Minneapolis, Minnesota)
StatusRecruiting
StartedAugust 25, 2021
Main results expectedSeptember 30, 2026
Study endsSeptember 30, 2026
Registry record updatedApril 8, 2026
Trial IDNCT05014165 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates include pediatric patients diagnosed with ALL or AML who have stored cord blood and are enrolled in the COG Project:EveryChild.

Probably not a fit

Patients who do not have stored cord blood or are not enrolled in the COG Project:EveryChild may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to collect and analyze banked cord blood samples from children diagnosed with acute lymphoblastic leukemia (ALL) or acute myeloid leukemia (AML). The research focuses on backtracking the genomic alterations present in these patients to identify the origins of leukemogenic mutations that may have occurred in utero. By characterizing pre-leukemic cells, the study seeks to develop a population-wide test for detecting circulating pre-leukemia. The study involves patient recruitment through the COG Project:EveryChild and requires stored diagnostic samples for analysis.

Why it matters

Potential benefit: If successful, this research could lead to early detection methods for pre-leukemia, potentially improving outcomes for children at risk of developing leukemia.

How similar studies have gone: While this approach is innovative, similar studies have shown promise in understanding the genetic basis of leukemia, suggesting potential for success.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

* 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 Criteria:

* 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's running

  • University of Minnesota/Masonic Cancer Center
    Minneapolis, Minnesota, United States
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.