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Completed

NCT Number: NCT03526666

Ascorbic Acid Levels in MDS, AML, and CMML Patients

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.

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Key information

Conditions

Myelodysplastic Syndromes AML Acute Myeloid Leukemia Bone Marrow Diseases CMML Chronic Disease Chronic Myelomonocytic Leukemia Disease Attributes Hematologic Diseases Hemic and Lymphatic Diseases Leukemia Leukemia, Myeloid Leukemia, Myeloid, Acute Leukemia, Myelomonocytic, Chronic MDS Myelodysplastic-Myeloproliferative Diseases Neoplasms Neoplasms by Histologic Type Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

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

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Peripheral Blood Collection

Other

Peripheral blood collection for the measurement of ascorbic acid levels and banking of plasma and buffy coat for future resrearch.

Primary outcomes

  1. Peripheral blood ascorbic acid levels

    Time frame: 1 year

    The level of ascorbic acid

Secondary outcomes

  1. Evaluation of human endogenous retroviral sequences (HERVs) expression

    Time frame: 1 year

  2. Evaluation of 5-methylcitosine (5-mC) and 5-hydroxymethylcytosine (5-hmC) levels

    Time frame: 1 year

Sponsors and collaborators

Lead sponsor

Van Andel Research Institute

Other

Registry information

Official study title

Collection of Peripheral Blood From Patients With Myelodysplastic Syndrome, Acute Myeloid Leukemia, or Chronic Myelomonocytic Leukemia for Measuring Baseline Ascorbic Acid Levels and Future Epigenetic Cancer Research

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
May 16, 2018
Registry last updated
Oct 3, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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