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Recruiting NCT05014165

Backtracking Leukemia-Typical Somatic Mutations in Cord Blood

— Observational Acute Lymphoblastic Leukemia Acute Myeloid Leukemia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Cord blood Sample Collection, Case identification and recruitment, Questionnaire Administration.
Who it may be relevant to
Registry conditions: Acute Lymphoblastic Leukemia, Acute Myeloid Leukemia. Basic parameters: up to 25 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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

Interventions

  • Other Cord blood Sample Collection
    Obtain banked cord blood samples from consecutive childhood leukemia patients
  • Other Case identification and recruitment
    Cases meeting eligibility and who have given consent through APEC14B1 for future contact for non-therapeutic studies
  • Other Questionnaire Administration
    The family will be given an option to complete questionnaire on paper, online, or over the telephone.

Primary outcome measures

  • 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]
Secondary outcome measures (1)
  • Density of alterations, calculated as # of alterations per # of cells assayed, within each flow-sorted cell population [Time frame: Up to 5 years]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Family-based

Study locations

United States · 1 center
  • University of Minnesota/Masonic Cancer Center — Minneapolis

Identifiers

NCT: NCT05014165 · AEPI20N1

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗