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Cancer Stem Cells in Acute Leukemia

Sponsor
Sanford Health (Other)
Overall Status
Recruiting
CT.gov ID
NCT03735797
Collaborator
(none)
50
Enrollment
2
Locations
59.6
Anticipated Duration (Months)
25
Patients Per Site
0.4
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Bone marrow aspirate or peripheral blood sample collection

Study Design

Study Type:
Observational
Anticipated Enrollment :
50 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Cancer Stem Cells in Acute Leukemia
Actual Study Start Date :
Jul 12, 2017
Anticipated Primary Completion Date :
Jul 1, 2022
Anticipated Study Completion Date :
Jul 1, 2022

Outcome Measures

Primary Outcome Measures

  1. ARID5B polymorphism/mutation status [5 years]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
1 Month to 30 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Sanford Health Fargo North Dakota United States 58102
2 Sanford Health Sioux Falls South Dakota United States 57104

Sponsors and Collaborators

  • Sanford Health

Investigators

  • Study Chair: Samuel Milanovich, MD, Sanford Health

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Sanford Health
ClinicalTrials.gov Identifier:
NCT03735797
Other Study ID Numbers:
  • SH Can Stem
First Posted:
Nov 8, 2018
Last Update Posted:
Nov 30, 2021
Last Verified:
Nov 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Leukemia
Acute Disease

Study Results

No Results Posted as of Nov 30, 2021