STUDY INCIDENCE AND CHARACTERISTICS OF MALIGNANT NEOPLASIES IN PATIENTS WITH HEMOGLOBINOPATHY FOLLOWED IN ITALY (Tum001)
STUDY MULTICENRIC OBSERVATIONAL, NO-PROFIT FOR THE INCIDENCE AND CHARACTERISTICS OF MALIGNANT NEOPLASIES IN PATIENTS WITH HEMOGLOBINOPATHY FOLLOWED IN ITALY
研究概览
地位
详细说明
By providing targeted screening strategies, these data may contribute to the early identification of tumor pathology in hemoglobinopathies, and, by contributing to the identification of risk factors, to its prevention. They will also be able to contribute to understanding which therapeutic approaches in the case of cancer are most appropriate in this category of subjects.
To be able to go even deeper into understanding the possible link that exists between tumors and hemoglobinopathy, a further data collection (substudy) has been prepared in which additional and more detailed information will be collected in order to evaluate which is the percentage of patients who develop tumors compared to all those with hemoglobinopathy.
The risk of developing tumors will also be assessed for each hemoglobinopathy (transfusion-dependent beta-thalassemia, transfusion independent beta-thalassemia, hemoglobin H disease, sickle cell disease, microdrepanocytosis)
研究类型
注册 (预期的)
联系人和位置
学习联系方式
- 姓名：RAFFAELLA ORIGA, MD
- 电话号码：528 39 070 6095655
- 邮箱：SECONDACASELLA@HOTMAIL.IT
学习地点
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Cagliari、意大利、09121
- 招聘中
- Azienda Ospedaliera Universitaria di Cagliari
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接触：
- RAFFAELLA ORIGA, MD
- 电话号码：-518 +39 070 6095655
- 邮箱：SECONDACASELLA@HOTMAIL.IT
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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
取样方法
研究人群
描述
Inclusion Criteria:
- Transfusion-dependent or independent beta-thalassemia, hemoglobin H disease, sickle cell anemia and microdrepanocytosis
- Current or previous malignant tumor pathology
- Availability of medical history including the most relevant clinical and instrumental data before the onset of cancer
Exclusion Criteria:
- - Other haematological diseases other than hemoglobinopathies
- Absence of neoplastic events in the clinical history
- Non-availability of relevant clinical and instrumental data
学习计划
研究是如何设计的？
设计细节
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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outcome 1
大体时间：ENROLLMENT STUDY
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Evaluate the number of patients with hemoglobinopathy followed at Italian centers that have developed neoplastic events in the last decades
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ENROLLMENT STUDY
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outcome 2
大体时间：enrollment study
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Evaluate which neoplasms are most associated with hemoglobinopathies
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enrollment study
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outcome 3
大体时间：enrollment study
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Identify any risk factors for the onset of neoplasms in patients with hemoglobinopathies.
|
enrollment study
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
outcome 4
大体时间：enrollment study
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To highlight the differences between the various hemoglobinopathies as regards the development and characteristics of neoplastic events
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enrollment study
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outcome 5
大体时间：enrollment study
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Evaluate the possible association between neoplastic events and martial accumulation parameters in the different hemoglobinopathies
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enrollment study
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outcome 6
大体时间：enrollment study
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Evaluate the incidence and prevalence of neoplasms with respect to the total population of patients with hemoglobinopathies
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enrollment study
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outcome 7
大体时间：enrollment study
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Evaluate the impact of neoplasms as a cause of death in patients with hemoglobinopathies compared to other causes
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enrollment study
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outcome 8
大体时间：enrollment study
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To evaluate the incidence rate of neoplasms in the total population of patients affected by hemoglobinopathies and in the various forms of hemoglobinopathy.
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enrollment study
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合作者和调查者
调查人员
- 首席研究员：RAFFAELLA ORIGA, MD、Azienda Ospedaliero Universitaria Di Cagliari
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 (实际的)
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.