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临床试验/NCT05584852
NCT05584852招募中不适用

Prognostic Value of Myosteatosis and Creatinine-to-cystatin C Ratio in Patients With Resectable Pancreatic Ductal Adenocarcinoma

The Affiliated Hospital of Qingdao University1 个研究点 分布在 1 个国家目标入组 240 人开始时间: 2022年11月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
240
试验地点
1
主要终点
overall survival

研究概览

简要总结

Pancreatic ductal adenocarcinoma (PDAC) is a dismal disease with a 5-year survival rate as low as 6%. It causes body composition changes and many patients develop muscle loss with disease progression. Computed tomography (CT) is a common, noninvasive method of muscle assessment.Known as myoesteatosis,low muscle radiodensity is reflective of intermuscular adipose tissue that influences survival outcomes in patients with cancer.Serum creatinine (Scr) and cystatin C (CysC) are usually employed to estimate renal function in clinical practice. Scr is a metabolic waste product produced by creatine in skeletal muscle. CysC can be produced by all nucleated cells in the body at a constant production rate. CysC is used as an endogenous marker to reflect the glomerular filtration rate. Some studies have supported that the Scr/CysC ratio (CCR) is a simple and inexpensive measure that can be used to evaluate the skeletal muscle mass of patients with malignancies, such as gastric cancer. Therefore, the purpose of the present study is to explore the association between CCR and myosteatosis upon diagnosis of PDAC, specially whether the co-occurrence of these factors could predict survival outcomes.Preoperative assessment of muscle quality may be valuable for treatment planning and optimization of nutritional support.

This retrospective study enrolls patients who underwent surgery for PDAC, from January 2016 to December 2021. Patients will be divided into myosteatosis and non-myosteatosis groups. Clinical and imaging data are collected.The study does not have any intervention measures and harm to subjects.

详细描述

Inclusion criteria:

a)aged between 18 and 75; b) pancreatic ductal adenocarcinoma confirmed by biopsy or postoperative pathology; c) CT and renal function related data within 1 month before operation; d) voluntarily participate in this study and have informed consent.

Exclusion criteria:

  • pancreatic malignant tumors of other pathological types or other malignant tumors;

  • received local or systemic radiotherapy and chemotherapy before operation; ③ with severe metabolic diseases such as decompensated cirrhosis, nervous system diseases and muscle degenerative diseases; ④ absent of preoperative imaging or clinical data;

研究设计

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

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • a) aged between 18 and 75; b) pancreatic ductal adenocarcinoma confirmed by biopsy or postoperative pathology; c) CT and renal function related data within 1 month before operation; d) voluntarily participate in this study and have informed consent.

排除标准

  • ① pancreatic malignant tumors of other pathological types or other malignant tumors;
  • received local or systemic radiotherapy and chemotherapy before operation;
  • with severe metabolic diseases such as decompensated cirrhosis, nervous system diseases and muscle degenerative diseases; ④ absent of preoperative imaging or clinical data; ⑤ Lost interviewers.

结局指标

主要结局

overall survival

时间窗: 2016.1.1-2022.12.31

Time from operation to death or the last follow-up

Disease free survival

时间窗: 2016.1.1-2022.12.31

Time from operation to recurrence or the last follow-up

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

jingxue

Prof

The Affiliated Hospital of Qingdao University

研究点 (1)

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