Ascorbic Acid Levels in MDS, AML, and CMML Patients

NCT ID: NCT03526666

Last Updated: 2019-10-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-11-01

Study Completion Date

2018-10-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Myelodysplastic Syndromes Acute Myeloid Leukemia Chronic Myelomonocytic Leukemia MDS AML CMML

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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

Intervention Type OTHER

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Peripheral blood collection

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

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Van Andel Research Institute

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Peter Jones

Cheif Scientific Officer

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Peter Jones, Ph.D., D.Sc.

Role: PRINCIPAL_INVESTIGATOR

Van Andel Research Institute

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Cancer and Hematology Centers of Western Michigan

Grand Rapids, Michigan, United States

Site Status

Metro Health - University of Michigan Health

Wyoming, Michigan, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 29102482 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27573823 (View on PubMed)

Provided Documents

Download supplemental materials such as informed consent forms, study protocols, or participant manuals.

Document Type: Study Protocol

View Document

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

17022

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Gemcitabine With Ascorbate Including Adolescents
NCT04877587 WITHDRAWN EARLY_PHASE1
Pharmacological Ascorbate for Lung Cancer
NCT02420314 COMPLETED PHASE2
IUdR/BUdR Cell Cycle Labelling
NCT00042250 COMPLETED NA
A Study of AL8326 in Healthy Subjects
NCT07132957 COMPLETED PHASE1