Acute Lymphoblastic LeukemiaNCT05014165
Backtracking Leukemia-Typical Somatic Mutations in Cord Blood
An observational study of Acute Lymphoblastic Leukemia and Acute Myeloid Leukemia, run by Children's Oncology Group at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 25 years
- Conditions the study is for
- Acute Lymphoblastic Leukemia, Acute Myeloid Leukemia
- What is being tested?
- Cord blood Sample Collection, Case identification and recruitment and Questionnaire Administration
- How many people
- 300 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Aug 2021to 30 Sep 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 25 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Patients diagnosed with acute lymphoblastic leukemia (ALL) or acute myeloid leukemia (AML).
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Minnesota/Masonic Cancer Center
Minneapolis, Minnesota, 55455
Logan Spector, PhD, 612-624-3912, spector@umn.edu
About this study
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.
Read the 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
- Being tested
- Cord blood Sample Collection, Case identification and recruitment, Questionnaire Administration
- Medical subject headings
- Precursor Cell Lymphoblastic Leukemia-Lymphoma, Leukemia, Myeloid, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cord blood Sample CollectionOther
Obtain banked cord blood samples from consecutive childhood leukemia patients
Case identification and recruitmentOther
Cases meeting eligibility and who have given consent through APEC14B1 for future contact for non-therapeutic studies
Questionnaire AdministrationOther
The family will be given an option to complete questionnaire on paper, online, or over the telephone.
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: Other: Cord blood Sample Collection; Other: Case identification and recruitment; Other: Questionnaire Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of patient-specific somatic alterations found in cord blood in each molecularly-defined subtype of leukemia leukemia patients in Project:EveryChild.
Investigate less common cytogenetic subtypes for which the prenatal origins have not yet been investigated.
Measured: up to 5 years
Secondary outcomes (1)
Density of alterations, calculated as # of alterations per # of cells assayed, within each flow-sorted cell population
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.
Measured: Up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2021
- Study start25 Aug 2021
- Primary completion30 Sep 2026 (estimated)
- Study completion30 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Lymphoblastic LeukemiaStudies of the same condition, open and under way.
- More trials run by Children's Oncology GroupThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Family based
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Children's Oncology Group
- Sponsor type
- Research network
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Adam de Smith, PhD, Study chair, Beckman Research Institute of the City of HopeLogan Spector, PhD, Study chair, Masonic Cancer Center, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05014165
- Sponsor's protocol ID
- AEPI20N1
- Status last verified
- Apr 2026
- First submitted
- 13 Aug 2021
- Last updated
- 8 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Backtracking Leukemia-Typical Somatic Mutations in Cord Blood
- ClinicalTrials.gov ID
- NCT05014165
- Acronym / sponsor ID
- AEPI20N1
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Children's Oncology GroupResearch network
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 25 Aug 2021 (actual)
- Primary completion
- 30 Sep 2026 (estimated)
- Study completion
- 30 Sep 2026 (estimated)
- First posted
- 20 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Family based
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ancillary-Correlative (Cord Blood collection) | – | Other: Cord blood Sample Collection, Other: Case identification and recruitment, Other: Questionnaire AdministrationAccrue patients with ALL and AML who indicate having banked cord blood at birth through the COG Project:EveryChild (APEC14B1) |
Who may qualify
- Ages
- Up to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Patients diagnosed with acute lymphoblastic leukemia (ALL) or acute myeloid leukemia (AML).
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cord blood Sample CollectionObtain banked cord blood samples from consecutive childhood leukemia patients | Other | Ancillary-Correlative (Cord Blood collection) |
| Case identification and recruitmentCases meeting eligibility and who have given consent through APEC14B1 for future contact for non-therapeutic studies | Other | Ancillary-Correlative (Cord Blood collection) |
| Questionnaire AdministrationThe family will be given an option to complete questionnaire on paper, online, or over the telephone. | Other | Ancillary-Correlative (Cord Blood collection) |
Primary outcome
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.
1 secondary outcome
Density of alterations, calculated as # of alterations per # of cells assayed, within each flow-sorted cell population
Time frame: Up to 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Adam de Smith, PhD study chair
Beckman Research Institute of the City of Hope
Logan Spector, PhD study chair
Masonic Cancer Center, University of Minnesota
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Lymphoblastic Leukemia and Acute Myeloid Leukemia, run by Children's Oncology Group at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Adam de Smith, PhD ((626) 218-4913, adesmith@coh.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2026.