Defining Inflammatory Markers of Cardiovascular Disease i... | NCT06692894

Studies
Defining Inflammatory Markers of Cardiovascular Disease in Patients With Myelodysplastic Syndromes

NCT06692894

Sponsor

University of Vermont

Status

Recruiting

Last Update Posted

Feb 3, 2026Actual

Enrollment

30Estimated

Phase

Not provided

Conditions

Myelodysplastic Syndromes, Adult

Interventions

Observational

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 5, 2024Actual

Primary Completion Date

Nov 2027Estimated

Completion Date

Nov 2027Estimated

First Submitted Date

Nov 14, 2024

First Submission Date that Met QC Criteria

Nov 14, 2024

First Posted Date

Nov 18, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 2, 2026

Last Update Posted Date

Feb 3, 2026Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Diego Adrianzen Herrera, Medical Oncologist, Assistant Professor, University of VermontPrincipal Investigator

Lead Sponsor

University of VermontOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

30Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Observational	Other	Blood will be collected from one cohort to identify potential blood biomarkers.	Adults with Myelodysplastic syndromes

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
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

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Vermont	Recruiting	Burlington	Vermont	05495-2038	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D009190	Myelodysplastic Syndromes

Ancestor Terms

ID	Term
D001855	Bone Marrow Diseases
D006402	Hematologic Diseases
D006425	Hemic and Lymphatic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D057832	Watchful Waiting

Ancestor Terms

ID	Term
D017063	Outcome Assessment, Health Care
D010043	Outcome and Process Assessment, Health Care
D011787	Quality of Health Care
D006298	Health Services Administration

Browse Leaves

Not provided

Browse Branches

Not provided