Ascorbic Acid Levels in MDS, AML, and CMML Patients

Completed

• Conditions: Chronic Myelomonocytic Leukemia; MDS; AML; Myelodysplastic Syndromes; Acute Myeloid Leukemia; CMML

• Registration Number: NCT03526666
• Lead Sponsor: Van Andel Research Institute

Brief Summary

This study is a non-interventional, specimen collection translational study to evaluate vitamin C levels in the peripheral blood of Acute Myeloid Leukemia (AML), Myelodysplastic Syndrome (MDS), or Chronic Myelomonocytic Leukemia (CMML) patients.

Detailed Description

It has previously been established that hematological cancer patients with myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML) often exhibit severe vitamin C deficiency from a cohort of patients in Copenhagen. In this study, the investigators aim to determine if those results are conserved in another population/geographical location.

Study Timeline

• Study Start: 2017-11-01
• Study First Submitted: 2018-05-03
• Study First Submitted QC: 2018-05-03
• Study First Posted: 2018-05-16
• Primary Completion: 2018-10-31
• Study Completion: 2018-10-31
• Status Verified: 2019-09
• Last Update Submitted: 2019-09-30
• Last Update Posted: 2019-10-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• Patients actively receiving treatment for acute myeloid leukemia (AML), myelodysplastic syndrome (MDS), or chronic myelomonocytic leukemia (CMML).
• Patients diagnosed with AML, MDS, or CMML and are treatment naïve.
• Patients who are 18 years old or older.

Exclusion Criteria

• Patients deemed as too ill to participate as determined by the clinical investigator.
• Non-English speaking patients
• Patients unable to provide informed consent.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Peripheral blood ascorbic acid levels	1 year	The level of ascorbic acid

Secondary Outcome Measures

Name	Time	Method
Evaluation of 5-methylcitosine (5-mC) and 5-hydroxymethylcytosine (5-hmC) levels	1 year
Evaluation of human endogenous retroviral sequences (HERVs) expression	1 year

Trial Locations

Locations (2)

Cancer and Hematology Centers of Western Michigan; 🇺🇸 Grand Rapids, Michigan, United States

Metro Health - University of Michigan Health; 🇺🇸 Wyoming, Michigan, United States