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Analysis of CMTM6 Expression in Patients With Acute Myeloid Leukemia

Sponsor
University of Freiburg (Other)
Overall Status
Recruiting
CT.gov ID
NCT05988047
Collaborator
(none)
150
Enrollment
1
Location
48
Anticipated Duration (Months)
3.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

In this study, we aim to investigate the expression of CKLF like MARVEL transmembrane domain containing 6 (CMTM6) in leukemia cells of patients with acute myeloid leukemia (AML). We will use peripheral blood samples and assess CMTM6 expression by flow cytometry and Western Blot.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    150 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Analysis of CMTM6 Expression in Patients With Acute Myeloid Leukemia
    Actual Study Start Date :
    May 1, 2020
    Anticipated Primary Completion Date :
    Feb 1, 2024
    Anticipated Study Completion Date :
    May 1, 2024

    Arms and Interventions

    Arm Intervention/Treatment
    Patients with AML

    Peripheral blood will be taken at the timepoint of primary diagnosis and analyzed for CMTM6 expression and T cell activation
    Healthy controls

    Peripheral blood will be taken analyzed for CMTM6 expression and T cell activation

    Outcome Measures

    Primary Outcome Measures

    1. CMTM6 expression (FC) [once at primary diagnosis]

      CMTM6 expression on blasts/monocytes will be measured by flow cytometry

    2. T cell activation (FC) [once at primary diagnosis]

      T cell activation and cytokine production will be measured by flow cytometry

    Secondary Outcome Measures

    1. CMTM6 expression (WB) [once at primary diagnosis]

      CMTM6 expression on blasts/monocytes will be measured by Western blot

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 99 Years
    Sexes Eligible for Study:
    All
    Inclusion Criteria:

    • age ≥ 18 years

    • primary diagnosis of acute myeloid leukemia

    • diagnosis results available

    • written informed consent

    • ability to understand the nature of the study and the study related procedures and to comply with them

    Exclusion Criteria:

    • age < 18 years

    • lack of informed consent

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Medical Center- University of Freiburg Freiburg CA Germany 79106

    Sponsors and Collaborators

    • University of Freiburg

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Robert Zeiser, Prof. Dr. med., University of Freiburg
    ClinicalTrials.gov Identifier:
    NCT05988047
    Other Study ID Numbers:
    • CMTM6_AML
    First Posted:
    Aug 14, 2023
    Last Update Posted:
    Aug 14, 2023
    Last Verified:
    Aug 1, 2023
    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
    Leukemia, Myeloid
    Leukemia, Myeloid, Acute

    Study Results

    No Results Posted as of Aug 14, 2023