Ascorbic Acid Levels in MDS, AML, and CMML Patients

Acute Myeloid Leukemia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03526666
• Other study ID #: 17022
• Status: Completed
• Start date: November 1, 2017
• Est. completion date: October 31, 2018

Study information

• Verified date: September 2019
• Source: Van Andel Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: October 31, 2018
• Est. primary completion date: October 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Acute Myeloid Leukemia
• AML
• Chronic Myelomonocytic Leukemia
• CMML
• Leukemia
• Leukemia, Myeloid
• Leukemia, Myeloid, Acute
• Leukemia, Myelomonocytic, Chronic
• Leukemia, Myelomonocytic, Juvenile
• MDS
• Myelodysplastic Syndromes
• Preleukemia
• Syndrome

Intervention

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

Locations

Country	Name	City	State
United States	Cancer and Hematology Centers of Western Michigan	Grand Rapids	Michigan
United States	Metro Health - University of Michigan Health	Wyoming	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Van Andel Research Institute

Country where clinical trial is conducted

United States, 

References & Publications (2)

Gillberg L, Ørskov AD, Liu M, Harsløf LBS, Jones PA, Grønbæk 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. Review. — View Citation

Liu M, Ohtani H, Zhou W, Ørskov AD, Charlet J, Zhang YW, Shen H, Baylin SB, Liang G, Grønbæk 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Peripheral blood ascorbic acid levels	The level of ascorbic acid	1 year
Secondary	Evaluation of human endogenous retroviral sequences (HERVs) expression		1 year
Secondary	Evaluation of 5-methylcitosine (5-mC) and 5-hydroxymethylcytosine (5-hmC) levels		1 year