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

Sponsor

Ruijin Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT03363685

Collaborator

(none)

140

Enrollment

Location

Anticipated Duration (Months)

2.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Spinal Metastases Non-Small-Cell Lung Cancer Metastatic

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.

Study Design

Study Type:

Observational

Anticipated Enrollment :

140 participants

Observational Model:

Cohort

Time Perspective:

Prospective

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

Actual Study Start Date :

Nov 1, 2017

Anticipated Primary Completion Date :

Nov 1, 2022

Anticipated Study Completion Date :

Nov 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
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.

Outcome Measures

Primary Outcome Measures

Survival [Every 6 months from date of diagnosis of NSCLC spinal metastasis until the date of death from any cause, assessed up to 3 years]
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.

Secondary Outcome Measures

Primary and Metastatic Lesions [Every 6 months from date of diagnosis of NSCLC spinal metastasis until the date of death from any cause, assessed up to 3 years]
Differences in the primary and metastatic lesions after therapy according to NCCN suggestion of NSCLC spinal metastasis patients from 3 different risk groups.
Serum Markers [Every 6 months from date of diagnosis of NSCLC spinal metastasis until the date of death from any cause, assessed up to 3 years]
Differences in the serum markers after therapy according to NCCN suggestion of NSCLC spinal metastasis patients from 3 different risk groups.
Visceral Metastasis [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 correlation between visceral metastasis and overall survival (OS) of NSCLC spinal metastasis patients
Visual Analogue Scale (VAS) [Every 6 months from date of diagnosis of NSCLC spinal metastasis until the date of death from any cause, assessed up to 3 years]
Assessment of pain level (1-10, higher value represents more pain)
Ambulatory Status [Every 6 months from date of diagnosis of NSCLC spinal metastasis until the date of death from any cause, assessed up to 3 years]
Assessment of walking ability
EORTC Quality of Life Questionnaire (QLQ) Bone metastasis (BM) 22, [Every 6 months from date of diagnosis of NSCLC spinal metastasis until the date of death from any cause, assessed up to 3 years]
Assessment of quality of life (22-88, higher value represents worse quality of life)
Modified Frankel grade [Every 6 months from date of diagnosis of NSCLC spinal metastasis until the date of death from any cause, assessed up to 3 years]
Assessment of neurological function (A-E, higher value represents better function)
The Spinal Instability Neoplastic Score (SINS) [Every 6 months from date of diagnosis of NSCLC spinal metastasis until the date of death from any cause, assessed up to 3 years]
Assessment of spinal instability (0-18, higher value represents worse instability)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.