Verification of Novel Survival Prediction Algorithm for Patients With NSCLC Spinal Metastasis

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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An Observational Study of Novel Survival Prediction Algorithm as Clinical Decision Support for Patients With Non-Small-Cell Lung Cancer (NSCLC) Spinal Metastasis

Conditions
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Spinal Metastases, Non-Small-Cell Lung Cancer Metastatic

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Low risk<br>For NSCLC spinal metastasis patients with 0-3 of novel survival prediction algorithm. | |
| Intermediate risk<br>For NSCLC spinal metastasis patients with 4-6 of novel survival prediction algorithm. | |
| High risk<br>For NSCLC spinal metastasis patients with 7-10 of novel survival prediction algorithm. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Survival Prediction, Spinal Metastases, Non Small Cell Lung Cancer Metastatic