RECRUITING

Backtracking Leukemia-Typical Somatic Mutations in Cord Blood

Conditions

Acute Lymphoblastic Leukemia Acute Myeloid Leukemia

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Backtracking Leukemia-Typical Somatic Mutations in Cord Blood

Quick Facts

Study Start:2021-08-25

Study Completion:2026-09-30

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05014165

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:Not specified to 25 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:CHILD, ADULT

Inclusion Criteria	Exclusion 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	* 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.

Inclusion Criteria

Exclusion 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

* 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.

Contacts and Locations

Study Contact

Adam de Smith, PhD

CONTACT

(323) 442-7953

desmith@usc.edu

Principal Investigator

Adam de Smith, PhD

STUDY_CHAIR

University of Southern California Keck School of Medicine

Logan Spector, PhD

STUDY_CHAIR

University of Minnesota Masonic Cancer Center

Study Locations (Sites)

University of Minnesota/Masonic Cancer Center

Minneapolis, Minnesota, 55455

United States

Collaborators and Investigators

Sponsor: Children's Oncology Group

Adam de Smith, PhD, STUDY_CHAIR, University of Southern California Keck School of Medicine
Logan Spector, PhD, STUDY_CHAIR, University of Minnesota Masonic Cancer Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-08-25

Study Completion Date2026-09-30

Study Record Updates

Study Start Date2021-08-25

Study Completion Date2026-09-30

Terms related to this study

Additional Relevant MeSH Terms

Acute Lymphoblastic Leukemia
Acute Myeloid Leukemia