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RecruitingNCT06327594Updated Mar 25, 2024

Assessment System of Sarcopenia in Lung Cancer Patients

An observational study in Sarcopenia, Lung Cancer and Ultrasound, sponsored by West China Hospital. Recruiting at 1 site in China. Open to participants aged 40 Years to 100 Years. Per ClinicalTrials.gov, last updated 2024-03-25.

Sponsored by West China Hospital · Observational

From the registry’s dates

  • Started Nov 2023; still recruiting 2 years 11 months later.
Study type
Observational
Model
Cohort
Time perspective
Cross-sectional
Enrollment
1,500
Ages
40 Years to 100 Years
Sex
All
01

Study summary

  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.
Read the 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.

02

Conditions studied

  • Sarcopenia
  • Lung Cancer
  • Ultrasound
03

In context

Lung Neoplasms

7,243 studies on the registry are indexed under Lung Neoplasms; 1,557 are open to participants now.

This study's planned enrollment of 1,500 is above the median of 189 across 1,514 observational studies indexed under Lung Neoplasms.

Browse Lung Neoplasms studies →

Lead sponsor

West China Hospital is the lead sponsor of 483 studies on the registry; 240 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
40 Years to 100 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Hospitalized patients scheduled for radical resection of lung cancer.

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

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.
05

Study design

Observational model
Cohort
Time perspective
Cross-sectional
Enrollment
1,500 participants (estimated)
Patient registry
No

Groups and cohorts

  • Lung cancer patients with sarcopenia

    Diagnostic Test: ultrasound scan · Diagnostic Test: CT/MRI scan

  • Lung cancer patients without sarcopenia

    Diagnostic Test: ultrasound scan · Diagnostic Test: CT/MRI scan

Interventions

  • Diagnostic testultrasound 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 testCT/MRI scan

    The patients with lung cancer who are scheduled to undergo radical resection of lung cancer are examined by abdominal CT/MRI.

06

What researchers measure

Primary outcomes

  1. Death

    Time frame: Within 2 years after the initial ultrasound examination

  2. 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.

    Time frame: Within 7 days after the surgery.

07

Study locations

1 of 1 sites recruiting
  • Xinyi Tang
    Chengdu, Sichuan, China
    • Xinyi Tang, Dr. · Contact · +8615680819215
    Recruiting
08

References and documents

Individual participant data

Plan to share: Undecided — By submitting an application to the project leader via email and obtaining approval from relevant hospital departments.

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 25, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06327594
Lead sponsor
West China Hospital
Responsible party
Xinyi Tang (Principal Investigator, West China Hospital) — Principal investigator
First posted
Mar 25, 2024
Start date
Nov 1, 2023
Primary completion
Nov 2027 (estimated)
Completion
Nov 2028 (estimated)
Last update
Mar 25, 2024

Study contacts

Xinyi Tang, Dr.
Contact
tangxinyi1996@outlook.com
+8615680819215
Xinyi Tang
principal investigator · Department of Medical Ultrasound, West China Hospital, Sichuan University

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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