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

NCT03363685 | Unknown

• 1 other identifier: RJ2017NO170
• Study Type: observational
• Target: 140
• Locations: 1 country
• Sites: 1

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.

Conditions

Spinal Metastases; Non-Small-Cell Lung Cancer Metastatic

Keywords

Survival Prediction; Spinal Metastases; Non Small Cell Lung Cancer Metastatic

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• 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

• 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

• 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

• 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

• 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

Study Arms (3)

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.

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

patients with NSCLC spinal metastasis aged 18-75.

You may qualify if:

• 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.

You may not qualify if:

• Diagnosis by biopsy: other tumors.
• Irregular follow-up and lost follow-up
• Withdraw from the study for any reason

Sponsors & Collaborators

• Ruijin Hospital: lead

Study Sites (1)

Ruijin Hospital Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, 200025, China

RECRUITING

Related Publications (1)

• 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.

  PMID: 31028506 DERIVED

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Chief Physician of Orthopaedics

Study Record Dates

• First Submitted: November 25, 2017
• First Posted: December 6, 2017
• Study Start: November 1, 2017
• Primary Completion: November 1, 2022
• Study Completion: November 1, 2022
• Last Updated: October 8, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)