NCT05014165 · Children's Oncology Group
Backtracking Leukemia-Typical Somatic Mutations in Cord Blood
What this study is about
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.
View original scientific description
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.
Interventions
OTHER
Cord blood Sample Collection
Obtain banked cord blood samples from consecutive childhood leukemia patients
OTHER
Case identification and recruitment
Cases meeting eligibility and who have given consent through APEC14B1 for future contact for non-therapeutic studies
OTHER
Questionnaire Administration
The family will be given an option to complete questionnaire on paper, online, or over the telephone.
Primary outcome measures
Prevalence of patient-specific somatic alterations found in cord blood in each molecularly-defined subtype of leukemia leukemia patients in Project:EveryChild.
Time frame: up to 5 years
Investigate less common cytogenetic subtypes for which the prenatal origins have not yet been investigated.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- Minneapolis, Minnesota
Collaborators
National Cancer Institute (NCI)
Related conditions & keywords
Frequently asked questions
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Will I receive a placebo instead of treatment?
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Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Apr 8, 2026 · Source of record for eligibility and locations