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临床试验/NCT04306094
NCT04306094Unknown不适用

Predictive Prognostic Factors in Patients With Non-small Cell Lung Cancer Stage IV

Instituto do Cancer do Estado de São Paulo1 个研究点 分布在 1 个国家目标入组 217 人开始时间: 2017年11月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
217
试验地点
1
主要终点
overall survival

研究概览

简要总结

This study is a cohort study with patients with advanced NSCLC. Patients will answer questionnaires about symptoms and quality of life and will be submitted to physical and blood tests, and computer tomography. The aim of this study is to estimate prognostic factors predicting survival to 3 months in patients with advanced NSCLC.

详细描述

Non-small-cell lung cancer (NSCLC) is currently the neoplasm leading in deaths worldwide and in Brazil. NSCLC has a high incidence, is usually diagnosed in advanced stages and has poor survival rates. The ability to refine the prognosis of a disease has implications at the time of diagnosis and decision about treatment. Clinical and laboratory factors are studied to evaluated the prognosis of diseases. Palliative Prognostic Score (PaP score), Karnofsky Performance Status Scale (KPS), Palliative Prognostic Index (PPI) are applied in patients with many types of solid tumors. The Charlson Score evaluates comorbidities and the attributed risk for presence it. Others predictors of prognostic are cachexia, quality of life, inflammatory factors, sarcopenia. There is a need to improve the ability to estimate the prognosis and to identify the factors responsible to low survival rates in patients with NSCLC diagnosed at advanced stage, also as a tool for a better treatment selection.

This is an observational and prospective study, including patients diagnosed with NSCLC and admitted in ICESP, staged as IV at admission, with no previous systemic treatment and classified as ECOG 2-4. Demographic data, presence of a caregiver, anthropometry, MRC dyspnea scale, KPS, Edmont Symptom Scale, Charlson's Comorbidity Score, PPI and PaP were evaluated in each patient. Evaluation of sarcopenia and cachexia with abdominal CT (Slice-O-Matic, v.5), arm circumference, handgrip strength test and quality of life using EORTC score QLQ C-30 and QLQ-CAX-24 were also evaluated. Significant prognostic factors will be selected by multivariate analysis in a training set estimated as 217 patients.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Advanced stage IVa or IVb NSCLC patients histologically diagnosis.
  • Eastern Cooperative Oncology Group Performance status 2 - 4
  • Treatment-naive

排除标准

  • Initiate treatment before initiate
  • psychiatric illnesses, except depression
  • pregnant or breastfeeding women
  • two concomitant neoplasms

结局指标

主要结局

overall survival

时间窗: 3 months

to assess overall survival in patients with NSCLC

次要结局

未报告次要终点

研究者

发起方
Instituto do Cancer do Estado de São Paulo
申办方类型
Other
责任方
Principal Investigator
主要研究者

Ana Paula de Souza Borges

physician, MD

Instituto do Cancer do Estado de São Paulo

研究点 (1)

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