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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03363685
Recruitment Status : Recruiting
First Posted : December 6, 2017
Last Update Posted : October 8, 2020
Sponsor:
Information provided by (Responsible Party):
Yuhui Shen, Ruijin Hospital

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
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.

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Study Type : Observational
Estimated 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 : November 1, 2017
Estimated Primary Completion Date : November 1, 2022
Estimated Study Completion Date : November 1, 2022

Resource links provided by the National Library of Medicine


Group/Cohort
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.



Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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.

  2. 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.

  3. 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

  4. 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)

  5. 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

  6. 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)

  7. 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)

  8. 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)



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
patients with NSCLC spinal metastasis aged 18-75.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03363685


Locations
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China, Shanghai
Ruijin Hospital Shanghai Jiao Tong University School of Medicine Recruiting
Shanghai, Shanghai, China, 200025
Contact: Yuhui Shen, Ph.D., M.D.    +8613918209875    yuhuiss@163.com   
Principal Investigator: Yuhui Shen, Ph.D., M.D.         
Principal Investigator: Weibin Zhang, Ph.D., M.D.         
Sub-Investigator: Shizhao Zang, M.D.         
Sub-Investigator: Qiyuan Bao, Ph.D., M.D.         
Sponsors and Collaborators
Ruijin Hospital
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Yuhui Shen, Associate Chief Physician of Orthopaedics, Ruijin Hospital
ClinicalTrials.gov Identifier: NCT03363685    
Other Study ID Numbers: RJ2017NO170
First Posted: December 6, 2017    Key Record Dates
Last Update Posted: October 8, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Yuhui Shen, Ruijin Hospital:
Survival Prediction
Spinal Metastases
Non Small Cell Lung Cancer Metastatic
Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Neoplasm Metastasis
Neoplasms, Second Primary
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Neoplastic Processes
Pathologic Processes