Trousseau Studie, Mortaliteit Door Maligniteit Bij patiënten Met Idiopatische Veneuze Tromboembolie
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 630
- 试验地点
- 10
- 主要终点
- Mortality
研究概览
简要总结
Background
Patients with an idiopathic venous thromboembolism (IVTE) appear to have a risk of approximately 10% for symptomatic malignancy within 3 years after the IVTE. It is not clear if extensive screening for malignant disease leads to survival benefit in patients with an IVTE.
The SOMIT study learned that it is feasible to screen patients with an IVTE for malignancy and screening by means of a computer tomography (CT) of the chest and abdomen plus a mammography in women had the potential to be most cost-effective. The SOMIT study could not show a survival benefit due to the design of the study.
Primary objective: cancer related mortality
Methods:
The Trousseau study has been designed as a multicenter, prospective concurrently controlled cohort study.
Inclusion criteria:
- Proven first symptomatic deep venous thromboembolic event;
- Without: known risk factor for venous thromboembolism.
Exclusion criteria:
- Proven deep venous thromboembolic event in the medical history, age under 40 years;
- Patients without signs of malignancy after routine investigations (medical history, physical examination, laboratory investigations and chest X-ray) were included. Depending on the standard care in the hospital of interest, one group of patients has been screened by means of CT-chest and abdomen plus mammography, the other group had no additional investigations. Follow-up was aimed to be 3 years in both groups (at 3, 6, 12, 24 and 36 months after the thromboembolic event).
Data like mortality rate, morbidity due to screening procedures, additional investigations, number of cancer patients detected by the extensive screening, number of cancer patients three years after the IVTE, number and kind of investigations performed and information about cancer treatment and hospitalization was collected. If this information indicate a survival benefit these data enable us to perform a cost-effectiveness analysis.
Endpoint: Mortality.
Statistics:
Based on the prevalence of occult malignancy in VTE patients, the nature and stage of malignancies, the expected mortality, the anticipated detection of cancers and the early treatment related decrease in mortality we needed, in order to detect a true difference of this size with a 80 percent power and a two-tailed certainty of five percent, 750 patients for each group. Therefore, a total of 1500 patients is required for this study.
详细描述
Study design:
Although a randomized design is ideal for most studies we preferred a multicenter, prospective concurrently controlled cohort study design for our study. This is based on the experiences with the SOMIT study, in which two of the members of the executive committee (MH Prins, JMMB Otten) were involved.
The SOMIT study originally was supposed to have been conducted in eight countries. Medical ethical committees in most countries however considered it unethical to conduct this randomized study. Either because of the fact that the study contained a control arm, or because the screening arm (and thus the study itself) was considered to be unethical.
Patients as well as physicians found it difficult to let fate decide whether or not a patient would be screened for cancer, even though it was not clear if screening was life-saving. Moreover, during the SOMIT study, physicians noticed that patients with IVTE had their cancer detected early if they were in the screening group. This made it even more difficult to withhold additional screening procedures in patients in the routine group.
Many physicians themselves showed a strong preference for one of the arms of the study. Therefore they did not include as many patients as they could.
研究设计
- 研究类型
- Observational
- 时间视角
- Prospective
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Proven first symptomatic deep venous thromboembolic event;
- •No known malignancy
- •Without: trauma of the legs, surgery within the last 2 months, immobilization within the last 2 months, thrombocytosis (> 1000 x 109), clinical severe dehydration, deficiency of anti-thrombin III, protein C/S, Factor V Leiden mutation , Prothrombine mutation or circulating lupus anticoagulants, pregnancy or post-partum period
- •No indication for malignancy at routine investigations(medical history, physical examination, routine blood tests and chest X-ray)
排除标准
- •Proven deep venous thromboembolic event in the medical history
- •age under 40 years;
结局指标
主要结局
Mortality
时间窗: at 3, 6, 12, 24, 36 months after inclusion and at the end of study
The responsible physician inform the investigators when a patient has died. The national registrar was checked at the end of the study for all patients
次要结局
- Residual objectified malignancy(at 3, 6, 12, 24, 36 months after inclusion)
- Recurrent objectified malignancy(at 3, 6, 12, 24, 36 after inclusion.)
- Malignancy detected by extensive screening, without alarm signs in routine examinations(at 3 months after inclusion)
- Costs of screening, of additional tests after screening(at end of study.)
- Medical complications of screening tests(at 3 + 6 months and end of study)