Clinical trial NCT03526666: Ascorbic Acid Levels in MDS, AML, and CMML Patients
Official 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Myelodysplastic Syndromes
Acute Myeloid Leukemia
Chronic Myelomonocytic Leukemia
MDS
AML
CMML
Keywords: Vitamin C
Ascorbic Acid
Epigenetics
5-hydroxymethylcytosine
5-methylcytosine
Lead sponsor: Van Andel Research Institute
Sponsor class: OTHER
First posted: 2018-05-16
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients seen in hematology/oncology clinics in Grand Rapids, MI

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Peripheral blood ascorbic acid levels
timeFrame: 1 year
Secondary outcomes:
measure: Evaluation of human endogenous retroviral sequences (HERVs) expression
timeFrame: 1 year
measure: Evaluation of 5-methylcitosine (5-mC) and 5-hydroxymethylcytosine (5-hmC) levels
timeFrame: 1 year
Other outcomes:
Locations:
city: Grand Rapids
country: United States
facility: Cancer and Hematology Centers of Western Michigan
state: Michigan
city: Wyoming
country: United States
facility: Metro Health - University of Michigan Health
state: Michigan
Study officials:
affiliation: Van Andel Research Institute
name: Peter Jones, Ph.D., D.Sc.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.