Myelodysplastic Syndromes, AdultNCT06692894
Defining Inflammatory Markers of Cardiovascular Disease in Patients With Myelodysplastic Syndromes
An observational study of Myelodysplastic Syndromes, Adult, run by University of Vermont at 1 site in United States.
Trial summary
Why Is This Research Study Being Conducted? The study wants to find out why people with a type of blood cancer called myelodysplastic syndromes (MDS) are more likely to have heart problems like heart disease and stroke. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myelodysplastic Syndromes, Adult
- What is being tested?
- Observational
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Nov 2024to Nov 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: All patients with MDS diagnosed and treated at UVMMC will be eligible.
Who may be able to join
- Age ≥18 years
- Histologically confirmed diagnosis of MDS by bone marrow biopsy morphology, using the 2022 World Health Organization (WHO) classification for myeloid neoplasms
- Eastern Cooperative Oncology Group (ECOG) performance status ≤3
- Expected survival of at least 6 months
- Ability to provide consent
Who cannot join
- Cases meeting 2022 WHO criteria of MDS with excess blasts 2 as initial diagnosis
- Hematopoietic stem cell transplantation expected within 6 months
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Vermont
Burlington, Vermont, 05495-2038
Diego Adrianzen Herrera, MD, (802) 656-4414, dadrianz@uvm.edu
Diego Adrianzen Herrera, MD
About this study
Official title: Defining Inflammatory Biomarkers of Cardiovascular Disease in Patients With Myelodysplastic Syndromes
Why Is This Research Study Being Conducted?
- The study wants to find out why people with a type of blood cancer called myelodysplastic syndromes (MDS) are more likely to have heart problems like heart disease and stroke.
- Researchers also want to see if certain proteins related to inflammation in the body can help predict these heart issues in MDS patients.
- By understanding this better, researchers hope to find new ways to detect and manage heart disease risks in people with MDS
Read the detailed description
What Is Involved in The Study?
- This study will follow patients with MDS over 6 months.
- Participants will come to the hospital for the first visit. Participants will learn about the study, sign papers to join the study, and share some basic health information. Participants will also give a blood sample of 10 milliliters after not eating overnight.
- After the first visit, participants will come back to the hospital once a week for 3 weeks to give more blood samples after fasting overnight.
- The study team will call participants the day before each scheduled blood draw to remind you of your appointment.
- Then participants will return to the hospital for another visits once a month for the next 5 months. Participants will talk about any changes in their health and give a blood sample at each visit.
- Participants won't get any treatment as part of this study, but their participation will help researchers learn how inflammation affects the health of people with MDS
- Researchers will collect a small amount of blood (6-10 mL) per visit
- These blood collections are a normal part of medical care and won't require participants to come in more often than usual. The frequency of visits will be part of the routine care for myelodysplastic syndrome at the cancer center. Extra blood will be collected during standard of care blood draws in the clinic.
- Sessions will take about 20 minutes.
- Conditions
- Myelodysplastic Syndromes, Adult
- Being tested
- Observational
- Keywords
- Myelodysplastic Syndromes, Hematology
- Medical subject headings
- Myelodysplastic Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ObservationalOther
Blood will be collected from one cohort to identify potential blood biomarkers.
| Study group | Role | What they receive |
|---|---|---|
| Adults with Myelodysplastic syndromes | All participants will be in one group. Participants will by adults with Myelodysplastic syndromes. Blood will be taken at regular appointments that are part of standard care. Receives: Other: Observational |
What is being measured
The primary outcome is the main question the study is designed to answer.
Biologic Variability of Markers of Inflammation in the Blood
The within- and between-person biologic variability of an inflammation proteome over a period of 6 months
Measured: over 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2024
- Study start5 Nov 2024
- Primary completionNov 2027 (estimated)
- Study completionNov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myelodysplastic Syndromes, AdultStudies 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
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Vermont
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Diego Adrianzen Herrera, University of Vermont
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06692894
- Sponsor's protocol ID
- STUDY00003256/UVMCC2406
- Status last verified
- Feb 2026
- First submitted
- 14 Nov 2024
- Last updated
- 3 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Defining Inflammatory Biomarkers of Cardiovascular Disease in Patients With Myelodysplastic Syndromes
- ClinicalTrials.gov ID
- NCT06692894
- Acronym / sponsor ID
- STUDY00003256/UVMCC2406
- Conditions
- Myelodysplastic Syndromes, Adult
- Keywords
- Myelodysplastic Syndromes, Hematology
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of VermontUniversity, hospital or other
- Study start
- 5 Nov 2024 (actual)
- Primary completion
- Nov 2027 (estimated)
- Study completion
- Nov 2027 (estimated)
- First posted
- 18 Nov 2024 (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.
Why Is This Research Study Being Conducted?
- The study wants to find out why people with a type of blood cancer called myelodysplastic syndromes (MDS) are more likely to have heart problems like heart disease and stroke.
- Researchers also want to see if certain proteins related to inflammation in the body can help predict these heart issues in MDS patients.
- By understanding this better, researchers hope to find new ways to detect and manage heart disease risks in people with MDS
Detailed description
What Is Involved in The Study?
- This study will follow patients with MDS over 6 months.
- Participants will come to the hospital for the first visit. Participants will learn about the study, sign papers to join the study, and share some basic health information. Participants will also give a blood sample of 10 milliliters after not eating overnight.
- After the first visit, participants will come back to the hospital once a week for 3 weeks to give more blood samples after fasting overnight.
- The study team will call participants the day before each scheduled blood draw to remind you of your appointment.
- Then participants will return to the hospital for another visits once a month for the next 5 months. Participants will talk about any changes in their health and give a blood sample at each visit.
- Participants won't get any treatment as part of this study, but their participation will help researchers learn how inflammation affects the health of people with MDS
- Researchers will collect a small amount of blood (6-10 mL) per visit
- These blood collections are a normal part of medical care and won't require participants to come in more often than usual. The frequency of visits will be part of the routine care for myelodysplastic syndrome at the cancer center. Extra blood will be collected during standard of care blood draws in the clinic.
- Sessions will take about 20 minutes.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adults with Myelodysplastic syndromes | – | Other: ObservationalAll participants will be in one group. Participants will by adults with Myelodysplastic syndromes. Blood will be taken at regular appointments that are part of standard care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients with MDS diagnosed and treated at UVMMC will be eligible.
Key inclusion criteria (5 listed)
- Age ≥18 years
- Histologically confirmed diagnosis of MDS by bone marrow biopsy morphology, using the 2022 World Health Organization (WHO) classification for myeloid neoplasms
- Eastern Cooperative Oncology Group (ECOG) performance status ≤3
- Expected survival of at least 6 months
- Ability to provide consent
Key exclusion criteria (2 listed)
- Cases meeting 2022 WHO criteria of MDS with excess blasts 2 as initial diagnosis
- Hematopoietic stem cell transplantation expected within 6 months
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 |
|---|---|---|
| ObservationalBlood will be collected from one cohort to identify potential blood biomarkers. | Other | Adults with Myelodysplastic syndromes |
Primary outcome
Biologic Variability of Markers of Inflammation in the Blood
Time frame: over 6 months
The within- and between-person biologic variability of an inflammation proteome over a period of 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2026.
- Individual participant dataSharing planned: No
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Clofarabine and Melphalan Before Donor Stem Cell Transplant in Treating Patients With Myelodysplasia, Acute Leukemia in Remission, or Chronic Myelomonocytic Leukemia
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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.
1 site 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, Adult, run by University of Vermont at 1 site 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 5 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 3 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Diego Adrianzen Herrera, MD ((802) 656-2021, dadrianz@med.uvm.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Biologic Variability of Markers of Inflammation in the Blood (time frame: over 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Feb 2026.