Backtracking Leukemia-Typical Somatic Mutations in Cord Blood
NCT ID: NCT05014165
Last Updated: 2025-03-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
300 participants
OBSERVATIONAL
2021-08-25
2026-09-30
Brief Summary
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Detailed Description
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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
Conditions
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Study Design
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FAMILY_BASED
PROSPECTIVE
Study Groups
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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)
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
25 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Children's Oncology Group
NETWORK
Responsible Party
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Principal Investigators
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Adam de Smith, PhD
Role: STUDY_CHAIR
University of Southern California Keck School of Medicine
Logan Spector, PhD
Role: STUDY_CHAIR
University of Minnesota Masonic Cancer Center
Locations
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University of Minnesota/Masonic Cancer Center
Minneapolis, Minnesota, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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AEPI20N1
Identifier Type: -
Identifier Source: org_study_id
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