Defining Inflammatory Markers of Cardiovascular Disease in Patients With Myelodysplastic Syndromes

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

Study Overview

• Status: Recruiting
• Conditions: Myelodysplastic Syndromes, Adult
• Intervention / Treatment: Other: Observational

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 Type: Observational
• Enrollment (Estimated): 30

Contacts and Locations

• Study Contact: Name: Diego Adrianzen Herrera, MD; Phone Number: (802) 656-2021; Email: dadrianz@med.uvm.edu
• Study Contact Backup: Name: Neil A Zakai, MD; Phone Number: (802) 656-2021; Email: neil.zakai@med.uvm.edu

Study Locations

• United States
  • Vermont
    • Burlington, Vermont, United States, 05495-2038
      • Recruiting
      • University of Vermont
      • Contact: Diego Adrianzen Herrera, MD; Phone Number: (802) 656-4414; Email: dadrianz@uvm.edu
      • Principal Investigator: Diego Adrianzen Herrera, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

All patients with MDS diagnosed and treated at UVMMC will be eligible.

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• Cases meeting 2022 WHO criteria of MDS with excess blasts 2 as initial diagnosis
• Hematopoietic stem cell transplantation expected within 6 months

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Other: Observational; Blood will be collected from one cohort to identify potential blood biomarkers.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	over 6 months

Collaborators and Investigators

• Sponsor: University of Vermont

Study record dates

Study Major Dates

• Study Start (Actual): November 5, 2024
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): November 1, 2027

Study Registration Dates

• First Submitted: November 14, 2024
• First Submitted That Met QC Criteria: November 14, 2024
• First Posted (Actual): November 18, 2024

Study Record Updates

• Last Update Posted (Actual): February 3, 2026
• Last Update Submitted That Met QC Criteria: February 2, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Hematology; Myelodysplastic Syndromes
• Additional Relevant MeSH Terms: Hematologic Diseases; Bone Marrow Diseases; Hemic and Lymphatic Diseases; Myelodysplastic Syndromes; Health Services Administration; Quality of Health Care; Outcome Assessment, Health Care; Outcome and Process Assessment, Health Care; Watchful Waiting
• Other Study ID Numbers: STUDY00003256/UVMCC2406

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No