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Trial Title:
Prognostic Value of Myosteatosis and Creatinine-to-cystatin C Ratio in Patients With Pancreatic Ductal Adenocarcinoma
NCT ID:
NCT05584852
Condition:
Skeletal Muscle Radiodensity
Myosteatosis
Scr/CysC Ratio
Pancreatic Ductal Adenocarcinoma
Conditions: Official terms:
Adenocarcinoma
Study type:
Observational
Overall status:
Unknown status
Study design:
Time perspective:
Retrospective
Summary:
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.
Detailed description:
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;
Criteria for eligibility:
Study pop:
This retrospective study enrolled patients who underwent surgery for resectable
pancreatic ductal adenocarcinoma, from January 2016 to December 2021. Patients will be
divided into myosteatosis and non-myosteatosis groups according to skeletal muscle
radiodensity.
Sampling method:
Probability Sample
Criteria:
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:
- 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
the Affiliated Hospital of Qingdao University
Address:
City:
Qingdao
Country:
China
Status:
Recruiting
Contact:
Last name:
Xue Jing
Phone:
18661807575
Email:
jingxue@qdu.edu.cn
Contact backup:
Last name:
Shenghua Bi
Phone:
18863608195
Email:
bsh112359@163.com
Start date:
November 1, 2022
Completion date:
May 1, 2023
Lead sponsor:
Agency:
The Affiliated Hospital of Qingdao University
Agency class:
Other
Source:
The Affiliated Hospital of Qingdao University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05584852
