Backtracking Leukemia-Typical Somatic Mutations in Cord Blood

Part of paid clinical trials in Minneapolis, Minnesota.

Sponsor
Children's Oncology Group
Study ID
NCT05014165
Status
Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
N/A - 25 Years
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Aug 25, 2021
Status verified
Apr 2026
Primary completion
Sep 30, 2026
Completion
Sep 30, 2026

Study Design

Enrollment
300 participants (estimated)

Arms

  • Arm: 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)

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 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Minnesota/Masonic Cancer CenterMinneapolisMinnesota55455
Logan Spector, PhD
612-624-3912

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