Cancer Stem Cells in Acute Leukemia | NCT03735797

Studies
Cancer Stem Cells in Acute Leukemia

NCT03735797

Sponsor

Sanford Health

Status

Active, not recruiting

Last Update Posted

Feb 10, 2026Actual

Enrollment

50Estimated

Phase

Not provided

Conditions

Acute Leukemia

Interventions

Bone marrow aspirate or peripheral blood sample collection

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2026

Overall Recruitment Status or Expanded Access Status

Active, not recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 12, 2017Actual

Primary Completion Date

Mar 1, 2028Estimated

Completion Date

Mar 1, 2029Estimated

First Submitted Date

Jul 26, 2018

First Submission Date that Met QC Criteria

Nov 7, 2018

First Posted Date

Nov 8, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 7, 2026

Last Update Posted Date

Feb 10, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

50Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Bone marrow aspirate or peripheral blood sample collection	Diagnostic Test	Collection of specimen samples only

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

1 Month

Maximum Age

30 Years

Standard Ages

ChildAdult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Sanford		Fargo	North Dakota	58102	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided