Etiology of the Platelet-Cancer Metastatic Pathway - A Study of Inflammatory Markers, Platelet Characteristics and Metastatic Surrogates in Cancer Patients and Controls
试验速览
- 阶段
- 不适用
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Platelet reactivity
研究概览
简要总结
The purpose of this research study is to understand if platelets in the blood become more active during cancer and specially advanced stages of cancer, in the future the investigators want to see if reducing platelet activity can improve survival in advanced cancer.
详细描述
Hypotheses for proposed study
Platelet reactivity as measured by percentage aggregation in response to agonists such as ADP is increased in patients with metastatic cancer compared to age sex and ethnicity matched controls.
Platelet activation as measured by release of cytokines and vasoactive substances such as VEGF, TGF-beta, and PDGF is increased in patients with metastatic cancer compared to age sex and ethnicity matched controls.
Study Design:
Single center matched case control design; matching variables are age, sex and ethnicity
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •25 adult patients (>18 years old) with any form of metastatic or advanced stage (TNM stage III or equivalent) solid adenocarcinoma including breast, colon, and lung cancer will be eligible for inclusion in this study with no restrictions related to previous chemotherapy, radiotherapy, biological therapy or surgical management at the time of enrollment or in the past., although we will prefer to recruit them prior to initiating chemotherapy.
- •25 patients will be selected based on age (+/- 5 years), sex and ethnicity matches from the outpatient medicine Clinic at Sinai hospital, as well as the Sinai community care clinic.
排除标准
- •Thrombocytopenia, defined as a platelet count of <100,000 at the time of
- •recruitment of in the last available laboratory data
- •History of known bleeding disorder or known platelet dysfunction
- •Patients on antiplatelet treatment or anticoagulant therapies at the time of enrollment or 10 days prior to testing
- •CKD stage IV or greater
研究组 & 干预措施
Control
Patients without cancer whose platelets are examined for comparison
干预措施: Everolimus (Drug)
Control
Patients without cancer whose platelets are examined for comparison
干预措施: Letrozole (Drug)
结局指标
主要结局
Platelet reactivity
时间窗: 1 day
次要结局
- Release of vasoactive substances, e.g. TGF Beta,(1 day)
研究者
Kenneth Miller, M.D.
Medical Oncologist
Sinai Hospital of Baltimore