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临床试验/NCT04714203
NCT04714203已完成不适用

Assessment of the Prevalence of Sarcopenia in Early Palliative Cancer Patients

Weprom1 个研究点 分布在 1 个国家目标入组 38 人开始时间: 2019年6月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
38
试验地点
1
主要终点
Prevalence of sarcopenia

研究概览

简要总结

Cancer is one of the leading causes of death in the world after cardiovascular disease (8.7 million deaths in 2015 for 17.5 million cases) 1. Despite a great deal of progress in disease detection and treatment, the incidence of cancer is steadily increasing (+ 33% in 2015) and particularly in certain locations (pancreas, lungs, brain and stomach), including risk factors are not always identified.

Advanced stage cancer (= metastatic) is most often incurable with the exception of germ cell tumors. Palliative care is then most often offered. Palliative care favors the patient's quality of life as a whole (medical, physical, psychological and social).

The symptoms most often reported by patients are: pain, fatigue, decreased appetite, nausea, and are directly related to phenomena such as cachexia, loss of autonomy and deterioration of psychological state, resulting in decreased overall survival. Chemotherapies and targeted therapies (immunotherapy, hormonal therapy, participation in a clinical trial) can provide a benefit in quality of life and survival only in the early phase (little benefit in the terminal phase).

Other prognostic factors can impact the quality of life and overall survival in these situations: sarcopenia and disorders of nutritional status (obesity, undernutrition).

The study of sarcopenia by CT scan of patients in a palliative situation is still too scarce. Sarcopenia is an often underestimated event and is associated with older age, co-morbidities, increased infectious complications, and early mortality.

The study of the prevalence of sarcopenia by CT scan would confirm its prognostic impact in a palliative situation.

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

  • age> 18 years old,
  • patient with solid cancer diagnosed with metastatic disease,
  • having had a biological assessment and a CT scan in the month preceding the medical consultation,
  • and whose prognosis is considered palliative

排除标准

  • age <18 years old,
  • adults under guardianship measure,
  • pregnancy or breastfeeding in progress,
  • malignant hemopathies,
  • metastatic germ cell tumors,
  • non-metastatic disease

结局指标

主要结局

Prevalence of sarcopenia

时间窗: 1 month

Number of patients with sarcopenia in the numerator out of the total number of patients included in the study in the denominator

次要结局

  • Progression free survival(6 months)
  • Event free survival(6 months)
  • Correlation between PRONOPALL score and sarcopenia(1 months)
  • Prevalence of undernutrition(1 month)
  • Overall survival(6 months)

研究者

发起方
Weprom
申办方类型
Other
责任方
Sponsor

研究点 (1)

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