Ascorbic Acid Levels in MDS, AML, and CMML Patients

September 30, 2019 updated by: Peter Jones, Van Andel Research Institute

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Michigan
      • Grand Rapids, Michigan, United States, 49503
        • Cancer and Hematology Centers of Western Michigan
      • Wyoming, Michigan, United States, 49519
        • Metro Health - University of Michigan Health

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients seen in hematology/oncology clinics in Grand Rapids, MI

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
AML, MDS, and CMML patients
Patients with a diagnosis of acute myeloid leukemia (AML), myelodysplastic syndrome (MDS), or chronic myelomonocytic leukemia (CMML).
Other: Peripheral blood collection
Peripheral blood collection for the measurement of ascorbic acid levels and banking of plasma and buffy coat for future resrearch.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Peripheral blood ascorbic acid levels
Time Frame: 1 year
The level of ascorbic acid
1 year

Secondary Outcome Measures

Outcome Measure
Time Frame
Evaluation of human endogenous retroviral sequences (HERVs) expression
Time Frame: 1 year
1 year
Evaluation of 5-methylcitosine (5-mC) and 5-hydroxymethylcytosine (5-hmC) levels
Time Frame: 1 year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Van Andel Research Institute

Investigators

  • Principal Investigator: Peter Jones, Ph.D., D.Sc., Van Andel Research Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

November 1, 2017

Primary Completion (ACTUAL)

October 31, 2018

Study Completion (ACTUAL)

October 31, 2018

Study Registration Dates

First Submitted

May 3, 2018

First Submitted That Met QC Criteria

May 3, 2018

First Posted (ACTUAL)

May 16, 2018

Study Record Updates

Last Update Posted (ACTUAL)

October 3, 2019

Last Update Submitted That Met QC Criteria

September 30, 2019

Last Verified

September 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 17022 (Registry Identifier: National Institute for Health Research Portfolio ID)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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