Assessment System of Sarcopenia in Lung Cancer Patients

Study on the Value of Musculoskeletal Cross-modal Imaging Assessment System in the Diagnosis and Prognosis of Sarcopenia in Lung Cancer Patients

1. To explore the diagnostic value of musculoskeletal cross-modal imaging assessment system of ultrasound combined with abdominal CT/MRI for sarcopenia in patients with lung cancer.
2. To explore the value of musculoskeletal cross-modal imaging assessment system of ultrasound combined with abdominal CT/MRI in evaluating the prognosis and the effect of nutritional support in patients with lung cancer during perioperative period.
3. To explore the value of musculoskeletal cross-modal imaging assessment system of ultrasound combined with abdominal CT/MRI in evaluating the long-term prognosis of patients with lung cancer.

Study Overview

• Status: Recruiting
• Conditions: Lung Cancer; Sarcopenia; Ultrasound
• Intervention / Treatment: Diagnostic test: ultrasound scan; Diagnostic test: CT/MRI scan

Detailed Description

Sarcopenia is a progressive and systemic skeletal muscle disease that involves accelerated loss of muscle mass and function and is associated with increased adverse outcomes in older adults such as falls, functional decline, weakness, and death. It can be comorbid with a variety of diseases and interacts extensively with various disease states to influence disease prognosis. According to literature reports, the prevalence of sarcopenia in lung cancer patients is 42.8%-45.0%, and many studies have confirmed that sarcopenia is associated with a variety of poor prognosis of lung cancer. Early identification of sarcopenia in lung cancer patients and early intervention before the surgery are very important steps to improve the prognosis of lung patients.

However, at present, the evaluation methods of sarcopenia are very complicated, which rely on three features: loss of muscle mass, loss of muscle strength, and loss of physical performance. At present, physicians usually use bioelectrical impedance analysis (BIA) or dual-energy X-ray absorptiometry (DXA) to determine skeletal muscle mass index SMI to measure muscle mass, grip strength test to measure muscle strength, gait speed or tools such as SPPB scores to assess physical performance. A diagnosis of sarcopenia can be made when a subject experiences a decrease in SMI combined with a decrease in grip strength or a decrease in gait speed. The above evaluation methods are difficult to be used as routine preoperative evaluation items.

Previous studies have demonstrated that SMI in older adults can be accurately estimated by using muscle thickness acquired from ultrasound examination with basic information such as age and body mass index (BMI). And it has been shown that the cross-sectional area of the psoas major muscle at L3-level assessed by CT/MRI can also preliminarily diagnose sarcopenia. However, existing alternatives for assessing sarcopenia with ultrasound or CT/MRI alone are incomplete and lack stability.

Fronted with such a dilemma, we attempted to establish a musculoskeletal cross-modal imaging evaluation system of ultrasound combined with abdominal CT/MRI images, which can diagnose sarcopenia more comprehensively and accurately, and evaluate the perioperative prognosis, nutritional support effect and long-term prognosis of patients.

• Study Type: Observational
• Enrollment (Estimated): 1500

Contacts and Locations

• Study Contact: Name: Xinyi Tang, Dr.; Phone Number: +8615680819215; Email: tangxinyi1996@outlook.com

Study Locations

• China
  • Sichuan
    • Chengdu, Sichuan, China
      • Recruiting
      • Xinyi Tang
      • Contact: Xinyi Tang, Dr.; Phone Number: +8615680819215

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Hospitalized patients scheduled for radical resection of lung cancer.

Description

Inclusion Criteria:

1. Hospitalized patients scheduled for radical resection of lung cancer.
2. With a CT/MRI examination within 1 week.
3. The compliance of examination was good.

Exclusion Criteria:

1. Amputated arm or leg.
2. Severe oedema (oedema higher than knee level).
3. Implantable pacemaker.
4. Impaired consciousness, poor general health, or other reasons that would prevent the individual from completing the study.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Lung cancer patients with sarcopenia	Diagnostic test: ultrasound scan; The patients with lung cancer who are scheduled to undergo radical resection of lung cancer are examined by ultrasound at multiple sites of the whole body, including muscle and fat.; Diagnostic test: CT/MRI scan; The patients with lung cancer who are scheduled to undergo radical resection of lung cancer are examined by abdominal CT/MRI.
Lung cancer patients without sarcopenia	Diagnostic test: ultrasound scan; The patients with lung cancer who are scheduled to undergo radical resection of lung cancer are examined by ultrasound at multiple sites of the whole body, including muscle and fat.; Diagnostic test: CT/MRI scan; The patients with lung cancer who are scheduled to undergo radical resection of lung cancer are examined by abdominal CT/MRI.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Death		Within 2 years after the initial ultrasound examination
Perioperative complications	Including local incision complications (infection, dehiscence); atelectasis/pulmonary infection; urinary tract infections; postoperative bleeding; deep venous thrombosis of the lower extremity; urinary retention; sepsis; hypoproteinemia, etc.	Within 7 days after the surgery.

Collaborators and Investigators

• Sponsor: West China Hospital
• Investigators: Principal Investigator: Xinyi Tang, Department of Medical Ultrasound, West China Hospital, Sichuan University

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2023
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): November 1, 2028

Study Registration Dates

• First Submitted: March 18, 2024
• First Submitted That Met QC Criteria: March 18, 2024
• First Posted (Actual): March 25, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2024
• Last Update Submitted That Met QC Criteria: March 18, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Neurologic Manifestations; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neuromuscular Manifestations; Pathological Conditions, Anatomical; Muscular Atrophy; Atrophy; Lung Neoplasms; Sarcopenia
• Other Study ID Numbers: XTang-0002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: By submitting an application to the project leader via email and obtaining approval from relevant hospital departments.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No