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临床试验/NCT06692894
NCT06692894招募中不适用

Defining Inflammatory Biomarkers of Cardiovascular Disease in Patients With Myelodysplastic Syndromes

University of Vermont1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2024年11月5日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
30
试验地点
1
主要终点
Biologic Variability of Markers of Inflammation in the Blood

研究概览

简要总结

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

详细描述

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.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •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

排除标准

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

研究组 & 干预措施

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.

干预措施: Observational (Other)

结局指标

主要结局

Biologic Variability of Markers of Inflammation in the Blood

时间窗: over 6 months

The within- and between-person biologic variability of an inflammation proteome over a period of 6 months

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Diego Adrianzen Herrera

Medical Oncologist, Assistant Professor

University of Vermont

研究点 (1)

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