Backtracking Leukemia-Typical Somatic Mutations in Cord Blood

Acute Myeloid Leukemia Clinical Trial

Official title:

Backtracking Leukemia-Typical Somatic Mutations in Cord Blood

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05014165
• Other study ID #: AEPI20N1
• Status: Recruiting
• Start date: August 25, 2021
• Est. completion date: September 30, 2026

Study information

• Verified date: December 2023
• Source: Children's Oncology Group
• Contact: Adam de Smith, PhD
• Phone: (323) 442-7953
• Email: desmith[@]usc.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: September 30, 2026
• Est. primary completion date: September 30, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 25 Years

Eligibility

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.

Related Conditions & MeSH terms

• Acute Lymphoblastic Leukemia
• Acute Myeloid Leukemia
• Leukemia
• Precursor Cell Lymphoblastic Leukemia-Lymphoma

Intervention

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

Locations

Country	Name	City	State
United States	University of Minnesota/Masonic Cancer Center	Minneapolis	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
Children's Oncology Group	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Density of alterations, calculated as # of alterations per # of cells assayed, within each flow-sorted cell population	Determine the prenatal origins across childhood leukemia subtypes, we will perform backtracking experiments using patient-specific ddPCR probes in matched tumor and CB samples from childhood ALL and AML patients in APEC14B1 with available stored CB. To identify the cells of origin of preleukemic alterations across childhood ALL and AML subtypes, we will perform single-cell sequencing analyses in flow-sorted CB cells from patients in which a prenatal lesion has been confirmed by backtracking.	Up to 5 years