Backtracking Leukemia-Typical Somatic Mutations in Cord Blood

Children's Oncology Group

Status

Enrolling

Conditions

Acute Lymphoblastic Leukemia

Acute Myeloid Leukemia

Treatments

Other: Cord blood Sample Collection

Other: Case identification and recruitment

Other: Questionnaire Administration

Study type

Observational

Funder types

NETWORK

NIH

Identifiers

NCT05014165

AEPI20N1

Details and patient eligibility

About

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.

Full 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

Enrollment

300 estimated patients

Sex

All

Ages

Under 25 years old

Volunteers

No Healthy Volunteers

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.