Recruiting

Observational Study

Sponsor:

Children's Oncology Group

Code:

NCT05014165

Conditions

Acute Lymphoblastic Leukemia

Acute Myeloid Leukemia

Eligibility Criteria

Sex: All

Age: 0 - 25

Healthy Volunteers: Not accepted

Interventions

Cord blood Sample Collection

Case identification and recruitment

Questionnaire Administration

Study Details

Brief 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.

Conditions

Acute Lymphoblastic Leukemia

Acute Myeloid Leukemia

Study ID

NCT05014165

Start date

Aug 25, 2021

Status verified date

Apr, 2026

Completion date

Sep 30, 2026

Anticipated

Primary completion date

Sep 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0 - 25

Healthy Volunteers: Not accepted

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

300 participants

Anticipated

Interventions and Outcome Measures

Arms

Ancillary-Correlative (Cord Blood collection)

Accrue patients with ALL and AML who indicate having banked cord blood at birth through the COG Project:EveryChild (APEC14B1)

Interventions

Cord blood Sample Collection

Obtain banked cord blood samples from consecutive childhood leukemia patients

Case identification and recruitment

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

Questionnaire Administration

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

Primary outcome measure

  • 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 ]

Central Contacts and Locations

Central contacts

Adam de Smith, PhD

(626) 218-4913adesmith@coh.org

Locations

University of Minnesota/Masonic Cancer Center

Recruiting

Minneapolis, Minnesota, United States, 55455

Contacts

Logan Spector, PhD

612-624-3912spector@umn.edu

More Information

Sponsor

Children's Oncology Group

Last update posted

Apr 8, 2026

Last verified

Apr, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Children's Oncology Group on 2026-04-08.