Cancer Stem Cells in Acute Leukemia

Descriptive study of acute leukemia patients. Bone marrow aspirate or peripheral blood samples will be analyzed by next-generation sequencing for novel gene signatures and variations in transcriptional and epigenetic regulatory elements such as ARID5B and SALL4 variants.

Study Overview

• Status: Active, not recruiting
• Conditions: Acute Leukemia
• Intervention / Treatment: Diagnostic test: Bone marrow aspirate or peripheral blood sample collection

• Study Type: Observational
• Enrollment (Estimated): 50

Contacts and Locations

Study Locations

• United States
  • North Dakota
    • Fargo, North Dakota, United States, 58102
      • Sanford

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 month to 30 years (Child, Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

The study team will enroll approximately 50 subjects (age 1 month to 30 years) with newly diagnosed or relapsed acute leukemia.

Description

Inclusion Criteria:

• Newly diagnosed or relapsed acute leukemia (AML or ALL)
• Plan to undergo diagnostic bone marrow aspirate or peripheral blood if clinically indicated (i.e. WBC>50,000 and bone marrow contraindicated)
• Age 1 month to 30 years
• Understand and provide informed consent (subject if>18, legal guardian if<18)

Exclusion Criteria:

• Age 0 to 4 weeks
• Treatment related leukemia or leukemia secondary to MDS
• Situations that would limit compliance with study requirements or ability to willingly give consent

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ARID5B polymorphism/mutation status	Correlation of our experimentally validated Arid5b dependent transcriptional signature with primary patient samples measured by patient ARID5B expression and polymorphisms.	5 years

Collaborators and Investigators

• Sponsor: Sanford Health
• Investigators: Study Chair: Samuel Milanovich, MD, Sanford Health

Study record dates

Study Major Dates

• Study Start (Actual): July 12, 2017
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): March 1, 2029

Study Registration Dates

• First Submitted: July 26, 2018
• First Submitted That Met QC Criteria: November 7, 2018
• First Posted (Actual): November 8, 2018

Study Record Updates

• Last Update Posted (Actual): February 10, 2026
• Last Update Submitted That Met QC Criteria: February 7, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms by Histologic Type; Neoplasms; Disease Attributes; Hematologic Diseases; Leukemia; Acute Disease
• Other Study ID Numbers: SH Can Stem

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No