Backtracking Leukemia-Typical Somatic Mutations in Cord Blood

NCT05014165 | Recruiting

• 1 other identifier: AEPI20N1
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Lymphoblastic Leukemia; Acute Myeloid Leukemia

Outcome Measures

Primary Outcomes (1)

• Prevalence of patient-specific somatic alterations found in cord blood in each molecularly-defined subtype of leukemia leukemia patients in Project:EveryChild.

  Investigate less common cytogenetic subtypes for which the prenatal origins have not yet been investigated.

  up to 5 years

Secondary Outcomes (1)

• Density of alterations, calculated as # of alterations per # of cells assayed, within each flow-sorted cell population

  Up to 5 years

Study Arms (1)

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)

Other: Cord blood Sample Collection; Other: Case identification and recruitment; Other: Questionnaire Administration

Interventions

Cord blood Sample Collection OTHER

Obtain banked cord blood samples from consecutive childhood leukemia patients

Ancillary-Correlative (Cord Blood collection)

Case identification and recruitment OTHER

Cases meeting eligibility and who have given consent through APEC14B1 for future contact for non-therapeutic studies

Ancillary-Correlative (Cord Blood collection)

Questionnaire Administration OTHER

The family will be given an option to complete questionnaire on paper, online, or over the telephone.

Ancillary-Correlative (Cord Blood collection)

Eligibility Criteria

• Age: Up to 25 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Patients diagnosed with acute lymphoblastic leukemia (ALL) or acute myeloid leukemia (AML).

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Cancer Institute (NCI): collaborator
• Children's Oncology Group: lead

Study Sites (1)

University of Minnesota/Masonic Cancer Center

Minneapolis, Minnesota, 55455, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Cord blood

MeSH Terms

Conditions

Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Myeloid, Acute

Condition Hierarchy (Ancestors)

Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Leukemia, Myeloid

Study Officials

• Adam de Smith, PhD

  Beckman Research Institute of the City of Hope

  STUDY CHAIR

• Logan Spector, PhD

  University of Minnesota Masonic Cancer Center

  STUDY CHAIR

Central Study Contacts

Adam de Smith, PhD

CONTACT

(626) 218-4913; adesmith@coh.org

Study Design

• Study Type: observational
• Observational Model: FAMILY BASED
• Time Perspective: PROSPECTIVE
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 13, 2021
• First Posted: August 20, 2021
• Study Start: August 25, 2021
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: April 8, 2026

Record last verified: 2026-04

Locations

US (1)