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

Spinal Metastases Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03363685
• Other study ID #: RJ2017NO170
• Status: Recruiting
• Start date: November 1, 2017
• Est. completion date: November 1, 2022

Study information

• Verified date: October 2020
• Source: Ruijin Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 140
• Est. completion date: November 1, 2022
• Est. primary completion date: November 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Neoplasm Metastasis
• Neoplasms, Second Primary
• Non-Small-Cell Lung Cancer Metastatic
• Spinal Metastases

Locations

Country	Name	City	State
China	Ruijin Hospital Shanghai Jiao Tong University School of Medicine	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Ruijin Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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