Ascorbic Acid Levels in MDS, AML, and CMML Patients

Sponsor

Van Andel Research Institute (Other)

Overall Status

Completed

CT.gov ID

NCT03526666

Collaborator

(none)

Enrollment

Locations

Actual Duration (Months)

Patients Per Site

2.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Myelodysplastic Syndromes Acute Myeloid Leukemia Chronic Myelomonocytic Leukemia MDS AML CMML	Other: Peripheral blood collection

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 Design

Study Type:

Observational

Actual Enrollment :

50 participants

Observational Model:

Case-Only

Time Perspective:

Prospective

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

Actual Study Start Date :

Nov 1, 2017

Actual Primary Completion Date :

Oct 31, 2018

Actual Study Completion Date :

Oct 31, 2018

Arms and Interventions

Arm	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.

Arm

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.

Outcome Measures

Primary Outcome Measures

Peripheral blood ascorbic acid levels [1 year]
The level of ascorbic acid

Secondary Outcome Measures

Evaluation of human endogenous retroviral sequences (HERVs) expression [1 year]
Evaluation of 5-methylcitosine (5-mC) and 5-hydroxymethylcytosine (5-hmC) levels [1 year]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Cancer and Hematology Centers of Western Michigan	Grand Rapids	Michigan	United States	49503
2	Metro Health - University of Michigan Health	Wyoming	Michigan	United States	49519