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

NCT ID: NCT03363685

Last Updated: 2020-10-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

140 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-11-01

Study Completion Date

2022-11-01

Brief Summary

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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

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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.

Conditions

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Spinal Metastases Non-Small-Cell Lung Cancer Metastatic

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Low risk

For NSCLC spinal metastasis patients with 0-3 of novel survival prediction algorithm.

No interventions assigned to this group

Intermediate risk

For NSCLC spinal metastasis patients with 4-6 of novel survival prediction algorithm.

No interventions assigned to this group

High risk

For NSCLC spinal metastasis patients with 7-10 of novel survival prediction algorithm.

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ruijin Hospital

OTHER

Sponsor Role lead

Responsible Party

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Yuhui Shen

Associate Chief Physician of Orthopaedics

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Ruijin Hospital Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, China

Site Status RECRUITING

Countries

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China

Facility Contacts

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Yuhui Shen, Ph.D., M.D.

Role: primary

+8613918209875

References

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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.

Reference Type DERIVED
PMID: 31028506 (View on PubMed)

Other Identifiers

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RJ2017NO170

Identifier Type: -

Identifier Source: org_study_id

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