Verification of Novel Survival Prediction Algorithm for Patients With NSCLC Spinal Metastasis
2020年10月6日 更新者：Yuhui Shen、Ruijin Hospital
An Observational Study of Novel Survival Prediction Algorithm as Clinical Decision Support for Patients With Non-Small-Cell Lung Cancer (NSCLC) Spinal Metastasis
The purpose of this study is to learn whether our own made predictive algorithm can be used as a clinical practical decision support for patients with NSCLC spinal metastasis.
The scoring system consists of the use of EGFR-TKI, KPS, Age, SCC, CA125 and smoking history.
By predicting survival doctors could determine which patients are suitable for palliative therapy.
研究概览
详细说明
Investigators have performed a retrospective study on 176 patients with NSCLC spinal metastasis under the oversight of hospital's ethics committee, and investigators found that the use of EGFR-TKI, KPS, Age, SCC, CA125 and smoking history had significant association with survival.
Then investigators built a simple, easy to use scoring system based on the features mentioned above.
The score was calculated as 1 (for patients didn't receive EGFR-TKI), +2 (for KPS <50%), +1 (for KPS 50-70%), +1 (Age >60years), 2 (SCC ≥1.5ng/ml), +3 (CA125 ≥35 U/ml), +1 (smoking history 1-10/day), +2 (smoking history >10/day), and 0 otherwise.
This algorithm was used to divide the patients into low risk (0-3), intermediate risk (4-6), high risk groups (7-10) to predict survival and determine which patients are suitable for palliative therapy.
Now investigators wish to register this study to do a further research, in order to verify the accuracy and sensitivity of this algorithm.
研究类型
观察性的
注册 (预期的)
140
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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Shanghai
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Shanghai、Shanghai、中国、200025
- 招聘中
- Ruijin Hospital Shanghai Jiao Tong University School of Medicine
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接触：
- Yuhui Shen, Ph.D., M.D.
- 电话号码：+8613918209875
- 邮箱：yuhuiss@163.com
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首席研究员：
- Yuhui Shen, Ph.D., M.D.
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首席研究员：
- Weibin Zhang, Ph.D., M.D.
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副研究员：
- Shizhao Zang, M.D.
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副研究员：
- Qiyuan Bao, Ph.D., M.D.
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 至 75年 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
取样方法
非概率样本
研究人群
patients with NSCLC spinal metastasis aged 18-75.
描述
Inclusion Criteria:
- Diagnosis by biopsy: Non-small-cell lung cancer, including non-squamous carcinoma and squamous cell carcinoma.
- Diagnosis through both nucleotide bone scan and MRI or PET-CT: spinal metastasis.
- Age 18-75 years.
- Have been or is about to be treated according to NCCN panel recommendation.
Exclusion Criteria:
- Diagnosis by biopsy: other tumors.
- Irregular follow-up and lost follow-up
- Withdraw from the study for any reason
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
队列和干预
团体/队列 |
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Low risk
For NSCLC spinal metastasis patients with 0-3 of novel survival prediction algorithm.
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Intermediate risk
For NSCLC spinal metastasis patients with 4-6 of novel survival prediction algorithm.
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High risk
For NSCLC spinal metastasis patients with 7-10 of novel survival prediction algorithm.
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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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Survival
大体时间：Every 6 months from date of diagnosis of NSCLC spinal metastasis until the date of death from any cause, assessed up to 3 years
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Accuracy and sensitivity of novel survival prediction algorithm derived from differences between the predicted and actual survival of NSCLC spinal metastasis patients from 3 different risk groups.
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Every 6 months from date of diagnosis of NSCLC spinal metastasis until the date of death from any cause, assessed up to 3 years
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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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Primary and Metastatic Lesions
大体时间：Every 6 months from date of diagnosis of NSCLC spinal metastasis until the date of death from any cause, assessed up to 3 years
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Differences in the primary and metastatic lesions after therapy according to NCCN suggestion of NSCLC spinal metastasis patients from 3 different risk groups.
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Every 6 months from date of diagnosis of NSCLC spinal metastasis until the date of death from any cause, assessed up to 3 years
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Serum Markers
大体时间：Every 6 months from date of diagnosis of NSCLC spinal metastasis until the date of death from any cause, assessed up to 3 years
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Differences in the serum markers after therapy according to NCCN suggestion of NSCLC spinal metastasis patients from 3 different risk groups.
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Every 6 months from date of diagnosis of NSCLC spinal metastasis until the date of death from any cause, assessed up to 3 years
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Visceral Metastasis
大体时间：Every 6 months from date of diagnosis of NSCLC spinal metastasis until the date of death from any cause, assessed up to 3 years
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The correlation between visceral metastasis and overall survival (OS) of NSCLC spinal metastasis patients
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Every 6 months from date of diagnosis of NSCLC spinal metastasis until the date of death from any cause, assessed up to 3 years
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Visual Analogue Scale (VAS)
大体时间：Every 6 months from date of diagnosis of NSCLC spinal metastasis until the date of death from any cause, assessed up to 3 years
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Assessment of pain level (1-10, higher value represents more pain)
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Every 6 months from date of diagnosis of NSCLC spinal metastasis until the date of death from any cause, assessed up to 3 years
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Ambulatory Status
大体时间：Every 6 months from date of diagnosis of NSCLC spinal metastasis until the date of death from any cause, assessed up to 3 years
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Assessment of walking ability
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Every 6 months from date of diagnosis of NSCLC spinal metastasis until the date of death from any cause, assessed up to 3 years
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EORTC Quality of Life Questionnaire (QLQ) Bone metastasis (BM) 22,
大体时间：Every 6 months from date of diagnosis of NSCLC spinal metastasis until the date of death from any cause, assessed up to 3 years
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Assessment of quality of life (22-88, higher value represents worse quality of life)
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Every 6 months from date of diagnosis of NSCLC spinal metastasis until the date of death from any cause, assessed up to 3 years
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Modified Frankel grade
大体时间：Every 6 months from date of diagnosis of NSCLC spinal metastasis until the date of death from any cause, assessed up to 3 years
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Assessment of neurological function (A-E, higher value represents better function)
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Every 6 months from date of diagnosis of NSCLC spinal metastasis until the date of death from any cause, assessed up to 3 years
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The Spinal Instability Neoplastic Score (SINS)
大体时间：Every 6 months from date of diagnosis of NSCLC spinal metastasis until the date of death from any cause, assessed up to 3 years
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Assessment of spinal instability (0-18, higher value represents worse instability)
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Every 6 months from date of diagnosis of NSCLC spinal metastasis until the date of death from any cause, assessed up to 3 years
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2017年11月1日
初级完成 (预期的)
2022年11月1日
研究完成 (预期的)
2022年11月1日
研究注册日期
首次提交
2017年11月25日
首先提交符合 QC 标准的
2017年11月30日
首次发布 (实际的)
2017年12月6日
研究记录更新
最后更新发布 (实际的)
2020年10月8日
上次提交的符合 QC 标准的更新
2020年10月6日
最后验证
2020年10月1日
更多信息
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