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Cancer Stem Cells in Acute Leukemia

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ClinicalTrials.gov Identifier: NCT03735797
Recruitment Status : Recruiting
First Posted : November 8, 2018
Last Update Posted : October 15, 2019
Sponsor:
Information provided by (Responsible Party):
Sanford Health

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
Acute Leukemia Diagnostic Test: Bone marrow aspirate or peripheral blood sample collection

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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Leukemia


Intervention Details:
  • Diagnostic Test: Bone marrow aspirate or peripheral blood sample collection
    Collection of specimen samples only


Primary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   1 Month to 30 Years   (Child, Adult)
Sexes Eligible for Study:   All
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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03735797


Contacts
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Contact: Kimberly Van Iperen 605-312-1081 kimberly.vaniperen@sanfordhealth.org

Locations
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United States, South Dakota
Sanford Health Recruiting
Sioux Falls, South Dakota, United States, 57104
Contact: Kimberly Van Iperen    605-312-1081    kimberly.veniperen@sanfordhealth.org   
Principal Investigator: Samuel Milanovich, MD         
Sponsors and Collaborators
Sanford Health
Investigators
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Study Chair: Samuel Milanovich, MD Sanford Health

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Responsible Party: Sanford Health
ClinicalTrials.gov Identifier: NCT03735797     History of Changes
Other Study ID Numbers: SH Can Stem
First Posted: November 8, 2018    Key Record Dates
Last Update Posted: October 15, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Leukemia
Acute Disease
Neoplasms by Histologic Type
Neoplasms
Disease Attributes
Pathologic Processes