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NCT Number: NCT05014165

Backtracking Leukemia-Typical Somatic Mutations in Cord Blood

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.

Recruiting

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Key information

Age range

Up to 25 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Minnesota/Masonic Cancer Center

Minneapolis, Minnesota, 55455, United States

Location status: Recruiting

Location contact

Logan Spector, PhD

CONTACT

[email protected]

612-624-3912

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Cord blood Sample Collection

Other

Obtain banked cord blood samples from consecutive childhood leukemia patients

Case identification and recruitment

Other

Cases meeting eligibility and who have given consent through APEC14B1 for future contact for non-therapeutic studies

Questionnaire Administration

Other

The family will be given an option to complete questionnaire on paper, online, or over the telephone.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Density of alterations, calculated as # of alterations per # of cells assayed, within each flow-sorted cell population

    Time frame: Up to 5 years

    Determine the prenatal origins across childhood leukemia subtypes, we will perform backtracking experiments using patient-specific ddPCR probes in matched tumor and CB samples from childhood ALL and AML patients in APEC14B1 with available stored CB. To identify the cells of origin of preleukemic alterations across childhood ALL and AML subtypes, we will perform single-cell sequencing analyses in flow-sorted CB cells from patients in which a prenatal lesion has been confirmed by backtracking.

Study contacts

Contact information is provided by the study sponsor or research team.

Adam de Smith, PhD

CONTACT

[email protected]

(626) 218-4913

Sponsors and collaborators

Lead sponsor

Children's Oncology Group

Network

Collaborators

  • National Cancer Institute (NCI)

Registry information

Important dates

Study start
2021
Primary completion
2026
Study completion
2026
First posted
Aug 20, 2021
Registry last updated
Apr 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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