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

NCT05584852 | Unknown

• 1 other identifier: QYFYWZLL27348
• Study Type: observational
• Target: 240
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Skeletal Muscle Radiodensity; Myosteatosis; Scr/CysC Ratio; Pancreatic Ductal Adenocarcinoma

Outcome Measures

Primary Outcomes (2)

• overall survival

  Time from operation to death or the last follow-up

  2016.1.1-2022.12.31

• Disease free survival

  Time from operation to recurrence or the last follow-up

  2016.1.1-2022.12.31

Study Arms (2)

with myosteatosis

without myosteatosis

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Affiliated Hospital of Qingdao University: lead

Study Sites (1)

the Affiliated Hospital of Qingdao University

Qingdao, Shandong, China

RECRUITING

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof

Study Record Dates

• First Submitted: October 14, 2022
• First Posted: October 18, 2022
• Study Start: November 1, 2022
• Primary Completion: March 1, 2023
• Study Completion: May 1, 2023
• Last Updated: November 8, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)