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

Overview

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.

Full Title of Study: “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

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: November 1, 2022

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.

Arms, Groups and Cohorts

  • 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.

Clinical Trial Outcome Measures

Primary Measures

  • Survival
    • Time Frame: 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 Measures

  • Primary and Metastatic Lesions
    • Time Frame: 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
    • Time Frame: 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
    • Time Frame: 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)
    • Time Frame: 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
    • Time Frame: 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,
    • Time Frame: 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
    • Time Frame: 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)
    • Time Frame: 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)

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 75 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Ruijin Hospital
  • Provider of Information About this Clinical Study
    • Principal Investigator: Yuhui Shen, Associate Chief Physician of Orthopaedics – Ruijin Hospital

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