NCT05988047

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2020

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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 Start

First participant enrolled

May 1, 2020

Completed
3.3 years until next milestone

First Submitted

Initial submission to the registry

August 4, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

August 14, 2023

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2024

Completed
Last Updated

May 8, 2024

Status Verified

May 1, 2024

Enrollment Period

4 years

First QC Date

August 4, 2023

Last Update Submit

May 6, 2024

Conditions

Outcome Measures

Primary Outcomes (2)

  • CMTM6 expression (FC)

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

    At primary diagnosis

  • T cell activation (FC)

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

    At primary diagnosis

Secondary Outcomes (1)

  • CMTM6 expression (WB)

    At primary diagnosis

Study Arms (2)

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

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients with AML at primary diagnosis ≥ 18 years of age or healthy probands ≥ 18 years of age

You may qualify if:

  • 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

You may not qualify if:

  • age \< 18 years
  • lack of informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical Center- University of Freiburg

Freiburg im Breisgau, CA, 79106, Germany

Location

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Condition Hierarchy (Ancestors)

Leukemia, MyeloidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

August 4, 2023

First Posted

August 14, 2023

Study Start

May 1, 2020

Primary Completion

May 1, 2024

Study Completion

May 1, 2024

Last Updated

May 8, 2024

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will not share

Locations