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Backtracking Leukemia-Typical Somatic Mutations in Cord Blood
NCT05014165 · Children's Oncology Group
In plain English
Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.
About this study
OBJECTIVES:
Primary Aim 1: To obtain stored cord blood and dried bloodspots of pediatric leukemia patients in Project:EveryChild.
Secondary Aim 2: To conduct preliminary backtracking and characterization of ALL- and AML-typical somatic mutations in cord blood and dried bloodspots.
OUTLINE:
Accrue patients with ALL and AML who indicate having banked cord blood at birth through the APEC14B1 intake questionnaire
Eligibility 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.
Study design
Enrollment target: 300 participants
Age groups: child, adult
Timeline
Starts: 2021-08-25
Estimated completion: 2026-09-30
Last updated: 2026-04-08
Interventions
Other: Cord blood Sample CollectionOther: Case identification and recruitmentOther: Questionnaire Administration
Primary outcomes
- • 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)
Sponsor
Children's Oncology Group · network
With: National Cancer Institute (NCI)
Contacts & investigators
ContactAdam de Smith, PhD · contact · adesmith@coh.org · (626) 218-4913
InvestigatorAdam de Smith, PhD · study_chair, Beckman Research Institute of the City of Hope
InvestigatorLogan Spector, PhD · study_chair, University of Minnesota Masonic Cancer Center
All locations (1)
University of Minnesota/Masonic Cancer CenterRecruiting
Minneapolis, Minnesota, United States