Clinical trial NCT05014165: Backtracking Leukemia-Typical Somatic Mutations in Cord Blood
Official title: Backtracking Leukemia-Typical Somatic Mutations in Cord Blood
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Acute Lymphoblastic Leukemia
Acute Myeloid Leukemia
Lead sponsor: Children's Oncology Group
Sponsor class: NETWORK
Collaborators: name: National Cancer Institute (NCI)
First posted: 2021-08-20
Enrollment: 300
Sex: ALL
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: FAMILY_BASED
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients diagnosed with acute lymphoblastic leukemia (ALL) or acute myeloid leukemia (AML).

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.

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 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.

Primary outcomes:
measure: Prevalence of patient-specific somatic alterations found in cord blood in each molecularly-defined subtype of leukemia leukemia patients in Project:EveryChild.
timeFrame: up to 5 years
Secondary outcomes:
measure: Density of alterations, calculated as # of alterations per # of cells assayed, within each flow-sorted cell population
timeFrame: Up to 5 years
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota/Masonic Cancer Center
state: Minnesota
Study officials:
affiliation: University of Southern California Keck School of Medicine
name: Adam de Smith, PhD
role: STUDY_CHAIR
affiliation: University of Minnesota Masonic Cancer Center
name: Logan Spector, PhD
role: STUDY_CHAIR
References: