Cancer-related Thromboembolic Disease (PROSPECT)
The Challenge of Cancer-related Thromboembolic Disease: Can we Better Predict the Risk?
Patients with cancer are at particularly high risk of venous thromboembolism (VTE). The guidelines therefore strongly recommend thromboprophylaxis but recent surveys clearly show that oncologists are reluctant to use it because of concern over bleeding, absence of validated risk stratification tools and uncertainties concerning the optimal thromboprophylaxis. Hence, it is a real challenge to identify the individual VTE risk of each cancer patient and individually tailor their thromboprophylaxis.
The study aims to identify thrombin generation test (TGT) as a reliable, standardized overall haemostasis assay that can be used to evaluate individual thrombosis risk
The secondary objectives are:
- To define the limits of TGT parameters that indicate thrombosis risk in cancer patients
- To evaluate values of other clotting activation markers in patients with cancer
Patients recently diagnosed with locally advanced or metastatic adenocarcinoma of any origin, who are scheduled for systemic chemotherapy, will be enrolled in the trial at baseline (Visit 1). Thrombin generating capacity will be measured within the first month following diagnosis and before the start of the chemotherapy (between Visit 1 and Visit 2) and subsequently at the end of the first cure line of chemotherapy (Visit 3). Patients will be followed up for a period of 1 year, or until the occurrence of a thromboembolic event. Two follow up visits are foreseen - 6-month (Visit 4) and 12-month (or at the end of trial - Visit 5) visits.
Patients eventually undergoing second-line chemotherapy during the course of the follow-up will remain on study.
The study will document all cases of symptomatic thromboembolic events together with the relevant diagnostic work-up.
研究概览
研究类型
注册 (预期的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名:Yesim DARGAUD, MD PHD
- 电话号码:+33 (0)4 72 11 88 25
- 邮箱:ydargaud@univ-lyon1.fr
学习地点
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Bron、法国、69500
- 招聘中
- Unité d'Hémostase Clinique Hôpital Louis Pradel
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接触:
- Yesim Dargaud, MD, PhD
- 电话号码:+33 (0)4 72 11 88 25
- 邮箱:ydargaud@univ-lyon1.fr
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首席研究员:
- Yesim Dargaud, MD, PhD
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Adult patients of both sexes with locally advanced or metastatic adenocarcinoma of any origin, who are scheduled for systemic chemotherapy
- Subjects having signed Informed Consent prior to initiation of any study procedure
- Covered by a Health System
Exclusion Criteria:
- Known bleeding or thrombophilia disorders
- Eastern Cooperative Oncology Group (ECOG) performance status ≥ 3
- Patient immobilized
- Confirmed venous thromboembolism in the last 12 months
- Active bleeding or bleedings in the last 4 weeks requiring hospitalization, transfusion, or surgical intervention
- Anticoagulant therapy at the moment of first sampling (at least one day off for Heparines and DOAc; at least 5 days off for VKA is needed)
- Antiplatelet therapy at the moment of first sampling (only if PRP TGA can be performed at site)
- Severe hepatic insufficiency
- Life expectancy of less than 3 months
- Pregnancy
学习计划
研究是如何设计的?
设计细节
- 主要用途:其他
- 分配:不适用
- 介入模型:单组作业
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的:Patients with adenocarcinoma
60 Patients recently diagnosed with locally advanced or metastatic adenocarcinoma of any origin, who are scheduled for systemic chemotherapy
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研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
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thrombin generation assay results
大体时间:7 months
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7 months
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次要结果测量
结果测量 |
大体时间 |
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Clotting activation markers: thrombin-antithrombin complexes (TAT)
大体时间:7 months
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7 months
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Clotting activation markers: prothrombin fragment F1+2
大体时间:7 months
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7 months
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Clotting activation markers: D-dimer
大体时间:7 months
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7 months
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合作者和调查者
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (预期的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.
Thrombin Generation Assay的临床试验
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Smith & Nephew, Inc.终止关节炎 | 类风湿关节炎 | 缺血性坏死 | 关节不稳定 | 断裂 | 疼痛,肩膀 | 关节炎,退行性 | 其他关节的创伤后关节病,肩部 | 肩袖肩袖综合征及相关疾病 | 关节外伤 | 脱臼,肩膀美国
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Foundation for Innovative New Diagnostics, SwitzerlandUNITAID完全的
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Memorial Sloan Kettering Cancer CenterXcovery Holding Company, LLC主动,不招人