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
|Condition or disease||Intervention/treatment|
|Acute Lymphoblastic Leukemia Acute Myeloid Leukemia||Other: Cord blood Sample Collection Other: Case identification and recruitment Other: Questionnaire Administration|
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.
Accrue patients with ALL and AML who indicate having banked cord blood at birth through the APEC14B1 intake questionnaire
|Study Type :||Observational|
|Estimated Enrollment :||300 participants|
|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|
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.
- 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.
- 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
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
|Contact: Adam de Smith, PhD||(323) firstname.lastname@example.org|
|United States, Minnesota|
|University of Minnesota/Masonic Cancer Center||Recruiting|
|Minneapolis, Minnesota, United States, 55455|
|Contact: Logan Spector, PhD 612-624-3912 email@example.com|
|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|