Clinical trial NCT03363685: Verification of Novel Survival Prediction Algorithm for Patients With NSCLC Spinal Metastasis
Official title: An Observational Study of Novel Survival Prediction Algorithm as Clinical Decision Support for Patients With Non-Small-Cell Lung Cancer (NSCLC) Spinal Metastasis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Spinal Metastases
Non-Small-Cell Lung Cancer Metastatic
Keywords: Survival Prediction
Spinal Metastases
Non Small Cell Lung Cancer Metastatic
Lead sponsor: Ruijin Hospital
Sponsor class: OTHER
First posted: 2017-12-06
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients with NSCLC spinal metastasis aged 18-75.

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Survival
timeFrame: 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 outcomes:
measure: Primary and Metastatic Lesions
timeFrame: 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: Serum Markers
timeFrame: 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: Visceral Metastasis
timeFrame: 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: Visual Analogue Scale (VAS)
timeFrame: 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: Ambulatory Status
timeFrame: 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: EORTC Quality of Life Questionnaire (QLQ) Bone metastasis (BM) 22,
timeFrame: 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: Modified Frankel grade
timeFrame: 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: The Spinal Instability Neoplastic Score (SINS)
timeFrame: Every 6 months from date of diagnosis of NSCLC spinal metastasis until the date of death from any cause, assessed up to 3 years
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Ruijin Hospital Shanghai Jiao Tong University School of Medicine
state: Shanghai
Study officials:
References:
citation: 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.