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Backtracking Leukemia-Typical Somatic Mutations in Cord Blood | Clinical Trials | Clareo Health

RECRUITING

Backtracking Leukemia-Typical Somatic Mutations in Cord Blood

NCT05014165•Children's Oncology Group

Summary

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.

Detailed Description

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

Age

0 - 25 years

Sex

ALL

Healthy Volunteers

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.

Locations (1)

University of Minnesota/Masonic Cancer Center

Minneapolis, Minnesota, United States

Key Dates

Start Date

August 25, 2021

Primary Completion Date

September 30, 2026

Completion Date

September 30, 2026

Last Updated

March 10, 2025

Enrollment

300

ESTIMATED participants

Conditions

Acute Lymphoblastic LeukemiaAcute Myeloid Leukemia

Interventions

Cord blood Sample Collection

OTHER

Case identification and recruitment

OTHER

Questionnaire Administration

OTHER

Contacts

Adam de Smith, PhD

CONTACT

(323) 442-7953 desmith@usc.edu

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 10, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

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Backtracking Leukemia-Typical Somatic Mutations in Cord Blood

Inclusion Criteria

Exclusion Criteria

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