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

6. oktober 2020 oppdatert av: Yuhui Shen, Ruijin Hospital

An Observational Study of Novel Survival Prediction Algorithm as Clinical Decision Support for Patients With Non-Small-Cell Lung Cancer (NSCLC) Spinal Metastasis

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.

Studieoversikt

Status

Ukjent

Forhold

Detaljert beskrivelse

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.

Studietype

Observasjonsmessig

Registrering (Forventet)

140

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

Kina
- Shanghai
  - Shanghai, Shanghai, Kina, 200025
    - Rekruttering
    - Ruijin Hospital Shanghai Jiao Tong University School of Medicine
    - Ta kontakt med:
      
      Yuhui Shen, Ph.D., M.D.
      
      Telefonnummer: +8613918209875
      
      E-post: yuhuiss@163.com
    - Hovedetterforsker:
      
      Yuhui Shen, Ph.D., M.D.
    - Hovedetterforsker:
      
      Weibin Zhang, Ph.D., M.D.
    - Underetterforsker:
      
      Shizhao Zang, M.D.
    - Underetterforsker:
      
      Qiyuan Bao, Ph.D., M.D.

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år til 75 år (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Prøvetakingsmetode

Ikke-sannsynlighetsprøve

Studiepopulasjon

patients with NSCLC spinal metastasis aged 18-75.

Beskrivelse

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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Antall grupper / kohorter

Kohorter og intervensjoner

Gruppe / Kohort
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.

Hva måler studien?

Primære resultatmål

Resultatmål	Tiltaksbeskrivelse	Tidsramme
Survival Tidsramme: 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.	Every 6 months from date of diagnosis of NSCLC spinal metastasis until the date of death from any cause, assessed up to 3 years

Sekundære resultatmål

Resultatmål	Tiltaksbeskrivelse	Tidsramme
Primary and Metastatic Lesions Tidsramme: 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.	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 Tidsramme: 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.	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 Tidsramme: 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	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) Tidsramme: 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)	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 Tidsramme: 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	Every 6 months from date of diagnosis of NSCLC spinal metastasis until the date of death from any cause, assessed up to 3 years
EORTC Quality of Life Questionnaire (QLQ) Bone metastasis (BM) 22, Tidsramme: 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)	Every 6 months from date of diagnosis of NSCLC spinal metastasis until the date of death from any cause, assessed up to 3 years
Modified Frankel grade Tidsramme: 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)	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 Spinal Instability Neoplastic Score (SINS) Tidsramme: 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)	Every 6 months from date of diagnosis of NSCLC spinal metastasis until the date of death from any cause, assessed up to 3 years

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Ruijin Hospital

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

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.

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

1. november 2017

Primær fullføring (Forventet)

1. november 2022

Studiet fullført (Forventet)

1. november 2022

Datoer for studieregistrering

Først innsendt

25. november 2017

Først innsendt som oppfylte QC-kriteriene

30. november 2017

Først lagt ut (Faktiske)

6. desember 2017

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

8. oktober 2020

Siste oppdatering sendt inn som oppfylte QC-kriteriene

6. oktober 2020

Sist bekreftet

1. oktober 2020

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

RJ2017NO170

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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