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临床试验/NCT05564923
NCT05564923招募中不适用

CARG, VES13, G8 Scales in Predicting Drug Toxicity in Patients Receiving Nivolumab

Namik Kemal University1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2022年9月2日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
100
试验地点
1
主要终点
grade 3-4 nivolumab toxicity

研究概览

简要总结

The Geriatric 8 (G8), Vulnerable Elders Survey (VES-13), and Cancer and Aging Research Group (CARG) questionnaires are among the main tests whose purpose is to predict the risk of chemotherapy-induced toxicity (CRT) and allow treatment. Investigators aimed to investigate the effect of using the G8, VES13, and CARG scales in the geriatric age group in cancer patients receiving nivolumab treatment in predicting side effects.

详细描述

Investigator aimed to examine whether the G8, VES13, and CARG scales can shed light on clinicians in predicting side effects during the use of nivolumab in geriatric cancer patients. In the chemotherapy unit, demographic information, diagnosis date of the disease, previous treatments, comorbidities, and CARG, VES13, and G8 questionnaires will be recorded face-to-face to the patients who meet the study criteria. In addition, routine hemogram and biochemistry tests, which were requested by the patient's follow-up physician before Nivolumab treatment and which will be requested by the patient's own physician during follow-up visits, will be recorded prospectively. Side effects that may occur during nivolumab treatment will be pursued at each visit. CTCA v.6. will be used for grading.

inclusion criteria

1-Advanced cancer patients whose nivolumab treatment was started by the physician followed up (independent of diagnosis) 2-60 years and over, 3-ECOG performance score 0-1 4-Patients who signed the informed consent form

exclusion criteria

  1. Under 60 years old
  2. Ecog score >1

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
60 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Advanced stage cancer patients who have been treated with nivolumab
  • be over 60 years old

排除标准

  • be under the age of 60

研究组 & 干预措施

group 1

Advanced cancer patients over 65 years of age receiving nivolumab

干预措施: there is no intervention (Drug)

结局指标

主要结局

grade 3-4 nivolumab toxicity

时间窗: one year from first patient enrolled

grading will be made according to the CTCA V.6

次要结局

未报告次要终点

研究者

发起方
Namik Kemal University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Asoc. Prof. Erdoğan Selçuk Şeber

Asoc Prof.

Namik Kemal University

研究点 (1)

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