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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low risk | For NSCLC spinal metastasis patients with 0-3 of novel survival prediction algorithm. | ||
| Intermediate risk | For NSCLC spinal metastasis patients with 4-6 of novel survival prediction algorithm. | ||
| High risk | For NSCLC spinal metastasis patients with 7-10 of novel survival prediction algorithm. |
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| Measure | Description | Time Frame |
|---|---|---|
| Survival | 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. | Every 6 months from date of diagnosis of NSCLC spinal metastasis until the date of death from any cause, assessed up to 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Primary and Metastatic Lesions | Differences in the primary and metastatic lesions after therapy according to NCCN suggestion of NSCLC spinal metastasis patients from 3 different risk groups. | 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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Inclusion Criteria:
Exclusion Criteria:
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patients with NSCLC spinal metastasis aged 18-75.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ruijin Hospital Shanghai Jiao Tong University School of Medicine | Recruiting | Shanghai | Shanghai Municipality | 200025 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31028506 | Derived | Zang S, He Q, Bao Q, Shen Y, Zhang W. Establishment and validation of a novel survival prediction scoring algorithm for patients with non-small-cell lung cancer spinal metastasis. Int J Clin Oncol. 2019 Sep;24(9):1049-1060. doi: 10.1007/s10147-019-01452-8. Epub 2019 Apr 26. |
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| Serum Markers |
Differences in the serum markers after therapy according to NCCN suggestion of NSCLC spinal metastasis patients from 3 different risk groups. |
| Every 6 months from date of diagnosis of NSCLC spinal metastasis until the date of death from any cause, assessed up to 3 years |
| Visceral Metastasis | The correlation between visceral metastasis and overall survival (OS) of NSCLC spinal metastasis patients | Every 6 months from date of diagnosis of NSCLC spinal metastasis until the date of death from any cause, assessed up to 3 years |
| Visual Analogue Scale (VAS) | Assessment of pain level (1-10, higher value represents more pain) | Every 6 months from date of diagnosis of NSCLC spinal metastasis until the date of death from any cause, assessed up to 3 years |
| Ambulatory Status | Assessment of walking ability | Every 6 months from date of diagnosis of NSCLC spinal metastasis until the date of death from any cause, assessed up to 3 years |
| EORTC Quality of Life Questionnaire (QLQ) Bone metastasis (BM) 22, | Assessment of quality of life (22-88, higher value represents worse quality of life) | Every 6 months from date of diagnosis of NSCLC spinal metastasis until the date of death from any cause, assessed up to 3 years |
| Modified Frankel grade | Assessment of neurological function (A-E, higher value represents better function) | Every 6 months from date of diagnosis of NSCLC spinal metastasis until the date of death from any cause, assessed up to 3 years |
| The Spinal Instability Neoplastic Score (SINS) | Assessment of spinal instability (0-18, higher value represents worse instability) | Every 6 months from date of diagnosis of NSCLC spinal metastasis until the date of death from any cause, assessed up to 3 years |