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Backtracking Leukemia-Typical Somatic Mutations in Cord Blood

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ClinicalTrials.gov Identifier: NCT05014165
Recruitment Status : Recruiting
First Posted : August 20, 2021
Last Update Posted : September 5, 2021
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Children's Oncology Group

Study Description
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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.

Condition or disease Intervention/treatment
Acute Lymphoblastic Leukemia Acute Myeloid Leukemia Other: Cord blood Sample Collection Other: Case identification and recruitment Other: Questionnaire Administration

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

Study Design
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Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Family-Based
Time Perspective: Prospective
Official Title: Backtracking Leukemia-Typical Somatic Mutations in Cord Blood
Actual Study Start Date : July 30, 2021
Estimated Primary Completion Date : September 30, 2026
Estimated Study Completion Date : September 30, 2026

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Leukemia

Groups and Cohorts
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Group/Cohort Intervention/treatment
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
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.


Outcome Measures
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Primary Outcome Measures :
  1. 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 ]
    Investigate less common cytogenetic subtypes for which the prenatal origins have not yet been investigated.


Secondary Outcome Measures :
  1. Density of alterations, calculated as # of alterations per # of cells assayed, within each flow-sorted cell population [ Time Frame: Up to 5 years ]
    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.


Biospecimen Retention:   Samples With DNA
Cord blood

Eligibility Criteria
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Ages Eligible for Study:   up to 25 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients diagnosed with acute lymphoblastic leukemia (ALL) or acute myeloid leukemia (AML).
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05014165


Contacts
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Contact: Adam de Smith, PhD (323) 442-7953 desmith@usc.edu

Locations
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United States, Minnesota
University of Minnesota/Masonic Cancer Center Recruiting
Minneapolis, Minnesota, United States, 55455
Contact: Logan Spector, PhD    612-624-3912    spector@umn.edu   
Sponsors and Collaborators
Children's Oncology Group
National Cancer Institute (NCI)
Investigators
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Study Chair: Adam de Smith, PhD University of Southern California Keck School of Medicine
Study Chair: Logan Spector, PhD University of Minnesota Masonic Cancer Center
More Information
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Responsible Party: Children's Oncology Group
ClinicalTrials.gov Identifier: NCT05014165    
Other Study ID Numbers: AEPI20N1
First Posted: August 20, 2021    Key Record Dates
Last Update Posted: September 5, 2021
Last Verified: August 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Leukemia
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Neoplasms by Histologic Type
Neoplasms
Leukemia, Lymphoid
 Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases