Clinical trial NCT06692894: Defining Inflammatory Markers of Cardiovascular Disease in Patients With Myelodysplastic Syndromes
Official title: Defining Inflammatory Biomarkers of Cardiovascular Disease in Patients With Myelodysplastic Syndromes
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Myelodysplastic Syndromes, Adult
Keywords: Myelodysplastic Syndromes
Hematology
Lead sponsor: University of Vermont
Sponsor class: OTHER
First posted: 2024-11-18
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients with MDS diagnosed and treated at UVMMC will be eligible.

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.

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

Primary outcomes:
measure: Biologic Variability of Markers of Inflammation in the Blood
timeFrame: over 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Burlington
country: United States
facility: University of Vermont
state: Vermont
Study officials:
References: