NCT05014165

Backtracking Leukemia-Typical Somatic Mutations in Cord Blood

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 300 (estimated)
• Sponsor: Children's Oncology Group · Network
• Sex: All
• Age: 25 Years
• Healthy volunteers: Not accepted

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

Conditions

• Acute Lymphoblastic Leukemia
• Acute Myeloid Leukemia

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2021-08-25
• Primary completion: 2026-09-30
• Completion: 2026-09-30
• First posted: 2021-08-20
• Last updated: 2026-04-08

Locations

1 site across 1 country: United States