- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03526666
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
-
-
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).
|
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
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
- Gillberg L, Orskov AD, Liu M, Harslof LBS, Jones PA, Gronbaek K. Vitamin C - A new player in regulation of the cancer epigenome. Semin Cancer Biol. 2018 Aug;51:59-67. doi: 10.1016/j.semcancer.2017.11.001. Epub 2017 Nov 2.
- Liu M, Ohtani H, Zhou W, Orskov AD, Charlet J, Zhang YW, Shen H, Baylin SB, Liang G, Gronbaek K, Jones PA. Vitamin C increases viral mimicry induced by 5-aza-2'-deoxycytidine. Proc Natl Acad Sci U S A. 2016 Sep 13;113(37):10238-44. doi: 10.1073/pnas.1612262113. Epub 2016 Aug 29.
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
Additional Relevant MeSH Terms
- Neoplasms by Histologic Type
- Neoplasms
- Bone Marrow Diseases
- Hematologic Diseases
- Precancerous Conditions
- Myelodysplastic-Myeloproliferative Diseases
- Myelodysplastic Syndromes
- Leukemia
- Leukemia, Myeloid
- Leukemia, Myeloid, Acute
- Preleukemia
- Leukemia, Myelomonocytic, Chronic
- Leukemia, Myelomonocytic, Juvenile
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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