NCT03735797

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
32mo left

Started Jul 2017

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress78%
Jul 2017Mar 2029

Study Start

First participant enrolled

July 12, 2017

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

July 26, 2018

Completed
4 months until next milestone

First Posted

Study publicly available on registry

November 8, 2018

Completed
9.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2028

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2029

Last Updated

February 10, 2026

Status Verified

February 1, 2026

Enrollment Period

10.6 years

First QC Date

July 26, 2018

Last Update Submit

February 7, 2026

Conditions

Acute Leukemia

Outcome Measures

Primary Outcomes (1)

  • 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

Interventions

Bone marrow aspirate or peripheral blood sample collectionDIAGNOSTIC_TEST

Collection of specimen samples only

Eligibility Criteria

Age1 Month - 30 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-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.

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sanford

Fargo, North Dakota, 58102, United States

Location

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 26, 2018

First Posted

November 8, 2018

Study Start

July 12, 2017

Primary Completion (Estimated)

March 1, 2028

Study Completion (Estimated)

March 1, 2029

Last Updated

February 10, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations

US(1)