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临床试验/NCT03477721
NCT03477721Unknown不适用

The Role of the Muscle-nervous System Interface in Cancer Cachexia

University of Roma La Sapienza1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2018年3月16日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
40
试验地点
1
主要终点
Agrin fragment c-terminus CAF in cancer and cancer cachexia

研究概览

简要总结

Sarcopenia is an important component of cachexia associated with cancer, and their high incidence in cancer patients emphasizes the need for a better understanding of its mechanisms, which can result in better therapeutic interventions to reverse this situation and improve the prognosis. Our hypothesis is that the plasma concentration of IL-6 and c-terminal agrin is directly correlated with the loss of muscle mass and development of cachexia.

详细描述

The agrin is a protein that acts on neuromuscular junctions (NMJs) promoting stabilization of same, which results in the maintenance and growth of muscle fibers, but the cleavage of agrin, a process by which is formed the agrin fragment C-terminus (CAF), has been linked to the development of sarcopenia, because its presence is directly linked to the reduction in the number of muscle fibers, increasing the heterogeneity of fiber size, presence of Central cores and increasing the proportion of type I fibers and consequently a greater degradation of lean body mass. Studies in mice show that the greatest cleavage of agrin carries on development of sarcopenia and human studies report that individuals with higher serum levels of sarcopenia CAF compared to individuals without sarcopenia.

Therefore, aiming at the complexity of cancer associated with the cachexia and the great importance of the maintenance of lean body mass to a better prognosis in disease, is of fundamental importance to elucidate the role of CAF and the factors associated with sarcopenia, the possible use of these proteins for diagnosis and the contribution that this clarification could bring in clinical therapy.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
18 Years 至 100 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • cancer diagnosis

排除标准

  • continuously use of anti-inflammatory medications;
  • present renal and/or liver failure,
  • inflammatory bowel disease or chronic inflammatory processes not related to cachexia.

结局指标

主要结局

Agrin fragment c-terminus CAF in cancer and cancer cachexia

时间窗: 1 month

To measure the contents of agrin fragment c-terminus (CAF) in plasma of patient with cancer and cancer cachexia.

Agrin fragment c-terminus (CAF) and IL-6 and lean body mass

时间窗: 1 month

To correlate levels of agrin fragment c-terminus (CAF) and IL-6 with the lean body mass

Agrin fragment c-terminus CAF and IL-6 levels

时间窗: 1 month

To correlate levels of agrin fragment c-terminus (CAF) and IL-6 plasma levels in patients with cancer and with cancer cachexia.

Agrin fragment c-terminus CAF in cancer sarcopenia

时间窗: 1 month

To analyze correlation between Agrin fragment c-terminus CAF and the lean body mass (CT-scan estimated) of patients with cancer and with cancer cachexia.

次要结局

未报告次要终点

研究者

发起方
University of Roma La Sapienza
申办方类型
Other
责任方
Principal Investigator
主要研究者

Alessandro Laviano

Alessandro Laviano, MD associate professor of Internal Medicine

University of Roma La Sapienza

研究点 (1)

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