Defining Inflammatory Markers of Cardiovascular Disease in Patients With Myelodysplastic Syndromes

NCT06692894 | Recruiting DMC

• 1 other identifier: STUDY00003256/UVMCC2406
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.
• 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

Conditions

Myelodysplastic Syndromes, Adult

Keywords

Myelodysplastic Syndromes; Hematology

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

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

Interventions

Observational OTHER

Blood will be collected from one cohort to identify potential blood biomarkers.

Adults with Myelodysplastic syndromes

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of Vermont: lead

Study Sites (1)

University of Vermont

Burlington, Vermont, 05495-2038, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples will be processed to test DNA from serum.

MeSH Terms

Conditions

Myelodysplastic Syndromes

Interventions

Watchful Waiting

Condition Hierarchy (Ancestors)

Bone Marrow Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Outcome Assessment, Health Care; Outcome and Process Assessment, Health Care; Quality of Health Care; Health Services Administration

Central Study Contacts

Diego Adrianzen Herrera, MD

CONTACT

(802) 656-2021; dadrianz@med.uvm.edu

Neil A Zakai, MD

CONTACT

(802) 656-2021; neil.zakai@med.uvm.edu

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Oncologist, Assistant Professor

Study Record Dates

• First Submitted: November 14, 2024
• First Posted: November 18, 2024
• Study Start: November 5, 2024
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): November 1, 2027
• Last Updated: February 3, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)