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

6. oktober 2020 opdateret af: 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.

Studieoversigt

Status

Ukendt

Betingelser

Detaljeret 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.

Undersøgelsestype

Observationel

Tilmelding (Forventet)

140

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Kina
    • Shanghai
      • Shanghai, Shanghai, Kina, 200025
        • Rekruttering
        • Ruijin Hospital Shanghai Jiao Tong University School of Medicine
        • Kontakt:
          • Yuhui Shen, Ph.D., M.D.
          • Telefonnummer: +8613918209875
          • E-mail: yuhuiss@163.com
        • Ledende efterforsker:
          • Yuhui Shen, Ph.D., M.D.
        • Ledende efterforsker:
          • Weibin Zhang, Ph.D., M.D.
        • Underforsker:
          • Shizhao Zang, M.D.
        • Underforsker:
          • Qiyuan Bao, Ph.D., M.D.

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 75 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
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
Foranstaltningsbeskrivelse
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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Ruijin Hospital

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

1. november 2017

Primær færdiggørelse (Forventet)

1. november 2022

Studieafslutning (Forventet)

1. november 2022

Datoer for studieregistrering

Først indsendt

25. november 2017

Først indsendt, der opfyldte QC-kriterier

30. november 2017

Først opslået (Faktiske)

6. december 2017

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

8. oktober 2020

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

6. oktober 2020

Sidst verificeret

1. oktober 2020

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • RJ2017NO170

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