Myelodysplastic SyndromesNCT03526666
Ascorbic Acid Levels in MDS, AML, and CMML Patients
An observational study of Myelodysplastic Syndromes and Acute Myeloid Leukemia, run by Van Andel Research Institute at 2 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myelodysplastic Syndromes, Acute Myeloid Leukemia, Chronic Myelomonocytic Leukemia
- What is being tested?
- Peripheral blood collection
- How many people
- 50 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Nov 2017to 31 Oct 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients seen in hematology/oncology clinics in Grand Rapids, MI
Who may be able to join
- 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.
Who cannot join
- Patients deemed as too ill to participate as determined by the clinical investigator.
- Non-English speaking patients
- Patients unable to provide informed consent.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Cancer and Hematology Centers of Western Michigan
Grand Rapids, Michigan, 49503
Metro Health - University of Michigan Health
Wyoming, Michigan, 49519
About this study
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
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.
Read the 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.
- Conditions
- Myelodysplastic Syndromes, Acute Myeloid Leukemia, Chronic Myelomonocytic Leukemia, MDS, AML, CMML
- Being tested
- Peripheral blood collection
- Keywords
- Vitamin C, Ascorbic Acid, Epigenetics, 5-hydroxymethylcytosine, 5-methylcytosine
- Medical subject headings
- Myelodysplastic Syndromes, Leukemia, Myeloid, Acute, Leukemia, Myelomonocytic, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peripheral blood collectionOther
Peripheral blood collection for the measurement of ascorbic acid levels and banking of plasma and buffy coat for future resrearch.
| Study group | Role | What they receive |
|---|---|---|
| AML, MDS, and CMML patients | Patients with a diagnosis of acute myeloid leukemia (AML), myelodysplastic syndrome (MDS), or chronic myelomonocytic leukemia (CMML). Receives: Other: Peripheral blood collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peripheral blood ascorbic acid levels
The level of ascorbic acid
Measured: 1 year
Secondary outcomes (2)
Evaluation of human endogenous retroviral sequences (HERVs) expression
Measured: 1 year
Evaluation of 5-methylcitosine (5-mC) and 5-hydroxymethylcytosine (5-hmC) levels
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2018
- Study start1 Nov 2017
- Primary completion31 Oct 2018
- Study completion31 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Myelodysplastic SyndromesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Van Andel Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Peter Jones, Van Andel Research Institute
- Investigators
- Peter Jones, Ph.D., D.Sc., Principal investigator, Van Andel Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03526666
- Sponsor's protocol ID
- 17022
- Status last verified
- Sep 2019
- First submitted
- 3 May 2018
- Last updated
- 3 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 29102482Liu 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.
PubMed 27573823
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03526666
- Acronym / sponsor ID
- 17022
- Conditions
- Myelodysplastic Syndromes, Acute Myeloid Leukemia, Chronic Myelomonocytic Leukemia, MDS, AML, CMML
- Keywords
- Vitamin C, Ascorbic Acid, Epigenetics, 5-hydroxymethylcytosine, 5-methylcytosine
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Van Andel Research InstituteUniversity, hospital or other
- Study start
- 1 Nov 2017 (actual)
- Primary completion
- 31 Oct 2018 (actual)
- Study completion
- 31 Oct 2018 (actual)
- First posted
- 16 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AML, MDS, and CMML patients | – | Other: Peripheral blood collectionPatients with a diagnosis of acute myeloid leukemia (AML), myelodysplastic syndrome (MDS), or chronic myelomonocytic leukemia (CMML). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients seen in hematology/oncology clinics in Grand Rapids, MI
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- Patients deemed as too ill to participate as determined by the clinical investigator.
- Non-English speaking patients
- Patients unable to provide informed consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Peripheral blood collectionPeripheral blood collection for the measurement of ascorbic acid levels and banking of plasma and buffy coat for future resrearch. | Other | AML, MDS, and CMML patients |
Primary outcome
Peripheral blood ascorbic acid levels
Time frame: 1 year
The level of ascorbic acid
2 secondary outcomes
Evaluation of human endogenous retroviral sequences (HERVs) expression
Time frame: 1 year
Evaluation of 5-methylcitosine (5-mC) and 5-hydroxymethylcytosine (5-hmC) levels
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2019.
- Background: PubMed 29102482Gillberg 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.
- Background: PubMed 27573823Liu 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peter Jones, Ph.D., D.Sc. principal investigator
Van Andel Research Institute
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Myelodysplastic Syndromes and Acute Myeloid Leukemia, run by Van Andel Research Institute at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Peripheral blood ascorbic acid levels (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03526666, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Oct 2019.