NCT05014165Recruiting

Backtracking Leukemia-Typical Somatic Mutations in Cord Blood

Source: ClinicalTrials.gov · Last updated 8 Apr 2026

Brief summary (registry, in English)

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.

Status (registry): Recruiting
Study type: Observational
Enrollment: 300 (estimated)
First submitted: 13 Aug 2021
Start date: 25 Aug 2021
Primary completion date: 30 Sept 2026
Lead sponsor: Children's Oncology Group
Diseases: Acute lymphoblastic leukaemia, Acute myeloid leukemia, Childhood cancers
NCT number: NCT05014165

What you commit to

Study type: Observational
Planned participants: 300
From 25 Aug 2021 to the primary completion date, 30 Sept 2026
1 site in 1 country
Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other

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.

Who the study is looking for

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

Age in the registry: - to 25 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

Site	City	Country	Site status
University of Minnesota/Masonic Cancer Center Coordinator of this site? Confirm its status	Minneapolis	United States	Recruiting

This page is information, not medical advice. Discuss any trial with your doctor.