结直肠肝转移的放射组学:新的预后生物标志物的鉴定。
结直肠肝转移患者肿瘤和肝肿瘤界面的放射组学特征。新的预后生物标志物的鉴定。
背景:肝转移(CLM)影响约一半的结直肠癌患者并决定患者的预后。 预后预测对于患者分配最适当的治疗至关重要,但现有参数并不能充分发挥这一作用。 肿瘤病理学和分子数据以及肝-肿瘤界面特征显示出主要的预后影响,但它们不包含在标准预后评分中,并且标准成像方式对它们的信息很少。 放射组学分析表明,可以很好地预测多种肿瘤的病理数据和患者预后,但其在 CLM 中的应用仍有待探索。
假设 术前识别 CLM 和肝肿瘤界面特征将改善预后预测和患者治疗分配。 与其他肿瘤一样,放射组学分析可以对病理数据的预测进行重大改进。 放射组学特征本身可能与预后有重大关联。
目标
该研究有以下终点:
- 与标准预后评分相比,评估肿瘤和肝肿瘤界面的放射组学特征是否可以改善接受肝脏手术的 CLM 患者的预后预测。
- 探索放射组学特征是否与病理数据相关。
- 探索放射学特征与标准放射学标准的比较,以评估肿瘤对化疗的反应。
- 将放射组学和详细病理学数据合并到单个预后评分中。
实验设计 该研究将结合回顾性(n = 300 名患者)和前瞻性(n = 400 名)在作者机构接受肝切除术的患者系列。 回顾性收集的患者将代表预后模型的训练数据集,包括标准预后因素加上放射组学特征,而前瞻性队列的前半部分 (n=200) 将是验证数据集(至少随访 30 个月)。 为了分析放射组学特征与病理细节和肿瘤对化疗反应的关联,前瞻性患者队列(n = 400,约 800 CLM)将用作训练和验证数据集(有关肝肿瘤界面的数据无法可靠评估)在回顾系列中)。 最后,所有前瞻性收集并进行充分随访的患者将有助于建立结合放射组学特征和详细病理学数据的综合预后评分。 将在预后分析中对每位患者进行评估;在评估放射组学和病理学数据之间的关联时,将进行每个病变的评估。 LifeX ® 软件将用于执行放射组学分析。 将跟踪肿瘤的感兴趣体积 (VOI)。 自动体积扩展将应用于肿瘤 VOI 以跟踪肝脏-肿瘤界面(扩展 5 毫米)。
预期结果本研究有望证明 CLM 和肝肿瘤界面的放射组学特征具有重要的预后作用,并且与病理学数据具有良好的相关性。 我们进一步相信,结合放射组学和病理学数据的预后评分可以进一步优化预后预测。
对癌症的影响我们的分析旨在通过识别影响预后和预测病理数据的放射组学特征来改善 CLM 预后预测,并提出放射组学和病理学数据的组合预后模型。 这些是基于术前预后驱动的治疗分配的精准医疗的基础。
研究概览
地位
研究类型
注册 (实际的)
联系人和位置
学习地点
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Milan
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Rozzano、Milan、意大利、20089
- Humanitas Research Hospital
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参与标准
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
取样方法
研究人群
描述
纳入标准:
- 因 CLM 接受肝脏手术的患者经最终病理证实
- 至少 1 个直径 >10 mm 的 CLM
- 术前 CT 成像可用于放射组学分析。
- 年龄>18岁
- 过去5年无其他恶性肿瘤
- CT手术间隔≤60天
排除标准:
- 肝切除术前 CRLM 的局部治疗
- CT 门脉相不足或影响分析的高密度材料伪影
- 临床数据不完整
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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预后预测
大体时间:2020-2024年
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与标准预后参数相比,评估 CLM 患者肿瘤和肝肿瘤界面的放射组学特征是否可以改善完全切除后的预后预测
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2020-2024年
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与病理数据的关联
大体时间:2020-2024年
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探讨 CLM 患者肿瘤和肝肿瘤界面的放射组学特征是否与病理数据相关,包括 TRG、活细胞百分比、肿瘤生长模式、界面肿瘤厚度、瘤周微转移和肿瘤中的免疫浸润以及瘤周区域和分子状态。
此外,还将探讨病理数据之间的任何关联
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2020-2024年
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预后评分
大体时间:2020-2024年
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在 CLM 患者的单一预后评分中实现肿瘤和肝肿瘤界面的放射组学特征和详细病理学数据
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2020-2024年
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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与放射学标准的比较
大体时间:2020-2024年
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探索放射组学特征与标准放射学标准(即
RECIST 和 mRECIST 标准)用于预测肿瘤对化疗的反应
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2020-2024年
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合作者和调查者
出版物和有用的链接
一般刊物
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研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
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
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