Study of Coronary Calcium Score as a Marker of Post-radiation Vascular Dysplasia in Adults Treated During Childhood for Cancer With Mediastinal Irradiation
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 500
- 试验地点
- 3
- 主要终点
- Incidence of a calcium score
研究概览
简要总结
To measure coronary calcium score in adults treated during childhood or adolescence for irradiation cancer in the heart and / or anthracycline area and compare them to determine whether irradiation of the heart area is associated with increased calcium score after adjustment for other cardiovascular risk factors (age, sex, smoking, dyslipidemia, obesity, diabetes, high blood pressure and renal failure).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 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
- 否
入选标准
- •Patients 18 years of age or older,
- •Treated for cancer during childhood, adolescence or young adulthood (≤25 years),
- •Treated with irradiation of the heart area (≥20% of ≥5Gy heart rate) and / or anthracycline (cumulative dose of doxorubicin equivalent ≥300mg/m^²),
- •In complete remission of their pediatric cancer for at least 10 years,
- •Patient affiliated to a social security scheme or beneficiary of such a scheme,
- •Patient Information and Signed Informed Consent.
排除标准
- •Perspective less than 10 years,
- •Persons deprived of liberty or guardianship (including trusteeship),
- •Impossibility of submitting to the medical follow-up of the test for geographical, social or psychological reasons,
- •Pregnant women.
- •Inclusion criteria for extension cohort:
- •Patients 30 years of age or older,
- •Treated for cancer during childhood, adolescence or young adulthood (≤25 years),
- •Treated with irradiation of the heart area (≥20% of ≥5Gy heart rate),
- •In complete remission of their pediatric cancer for at least 10 years,
- •Patient affiliated to a social security scheme or beneficiary of such a scheme,
- •Patient Information and Signed Informed Consent.
- •Exclusion criteria for extension cohort:
- •Persons deprived of liberty or guardianship (including trusteeship),
- •Impossibility of submitting to the medical follow-up of the test for geographical, social or psychological reasons,
- •Pregnant women.
研究组 & 干预措施
Patients treated for cancer during childhood or adolescence
Patients over the age of 18 treated during childhood or adolescence for cancer with irradiation affecting the heart area (≥20% of ≥5Gy heart volume) and / or anthracyclines (≥ 300mg/m^²)
干预措施: Coronal calcium score measurement (Other)
结局指标
主要结局
Incidence of a calcium score
时间窗: Up to 24 months
Incidence of a calcium score measured by the Agatston score\> 0 in the study population of adults treated during childhood or adolescence for cancer with irradiation of the heart area and / or treatment with anthracyclines
次要结局
未报告次要终点