Cancer Stem Cells in Acute Leukemia

Sanford Health1 site in 1 country50 target enrollmentJuly 12, 2017

ConditionsAcute Leukemia

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Acute Leukemia
Sponsor: Sanford Health
Enrollment: 50
Locations: 1
Primary Endpoint: ARID5B polymorphism/mutation status
Status: Active, not recruiting
Last Updated: 2 months ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

July 12, 2017

End Date

March 1, 2029

Last Updated

2 months ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Sanford Health

Responsible Party

Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

ARID5B polymorphism/mutation status

Time Frame: 5 years

Correlation of our experimentally validated Arid5b dependent transcriptional signature with primary patient samples measured by patient ARID5B expression and polymorphisms.