NCT03526666

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Nov 2017

Shorter than P25 for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2017

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

May 3, 2018

Completed
13 days until next milestone

First Posted

Study publicly available on registry

May 16, 2018

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2018

Completed
Last Updated

October 3, 2019

Status Verified

September 1, 2019

Enrollment Period

12 months

First QC Date

May 3, 2018

Last Update Submit

September 30, 2019

Conditions

Myelodysplastic SyndromesAcute Myeloid LeukemiaChronic Myelomonocytic LeukemiaMDSAMLCMML

Keywords

Vitamin CAscorbic AcidEpigenetics5-hydroxymethylcytosine5-methylcytosine

Outcome Measures

Primary Outcomes (1)

  • Peripheral blood ascorbic acid levels

    The level of ascorbic acid

    1 year

Secondary Outcomes (2)

  • Evaluation of human endogenous retroviral sequences (HERVs) expression

    1 year

  • Evaluation of 5-methylcitosine (5-mC) and 5-hydroxymethylcytosine (5-hmC) levels

    1 year

Study Arms (1)

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

Interventions

Peripheral blood collectionOTHER

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

AML, MDS, and CMML patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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.

You may not qualify if:

  • Patients deemed as too ill to participate as determined by the clinical investigator.
  • Non-English speaking patients
  • Patients unable to provide informed consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Cancer and Hematology Centers of Western Michigan

Grand Rapids, Michigan, 49503, United States

Location

Metro Health - University of Michigan Health

Wyoming, Michigan, 49519, United States

Location

Related Publications (2)

  • 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.

    PMID: 29102482BACKGROUND

  • 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.

    PMID: 27573823BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

1. Plasma with ascorbic acid redox analysis prep (additive: MPA solution, 10 % meta-phosphoric acid w/v containing 2 mM Na2EDTA) 2. Plasma 3. Buffy coat pellet

MeSH Terms

Conditions

Myelodysplastic SyndromesLeukemia, Myeloid, AcuteLeukemia, Myelomonocytic, Chronic

Condition Hierarchy (Ancestors)

Bone Marrow DiseasesHematologic DiseasesHemic and Lymphatic DiseasesLeukemia, MyeloidLeukemiaNeoplasms by Histologic TypeNeoplasmsMyelodysplastic-Myeloproliferative DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Peter Jones, Ph.D., D.Sc.

    Van Andel Research Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Cheif Scientific Officer

Study Record Dates

First Submitted

May 3, 2018

First Posted

May 16, 2018

Study Start

November 1, 2017

Primary Completion

October 31, 2018

Study Completion

October 31, 2018

Last Updated

October 3, 2019

Record last verified: 2019-09

Locations

US(2)