SarcopeniaNCT06327594
Assessment System of Sarcopenia in Lung Cancer Patients
An observational study of Sarcopenia and Lung Cancer, run by West China Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 100 years
- Conditions the study is for
- Sarcopenia, Lung Cancer, Ultrasound
- What is being tested?
- ultrasound scan and CT/MRI scan
- How many people
- 1,500 participants
- Where
- 1 siteChina
- Study dates
- 1 Nov 2023to Nov 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Hospitalized patients scheduled for radical resection of lung cancer.
Who may be able to join
- Hospitalized patients scheduled for radical resection of lung cancer.
- With a CT/MRI examination within 1 week.
- The compliance of examination was good.
Who cannot join
- Amputated arm or leg.
- Severe oedema (oedema higher than knee level).
- Implantable pacemaker.
- Impaired consciousness, poor general health, or other reasons that would prevent the individual from completing the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Xinyi Tang
Chengdu, Sichuan
Xinyi Tang, Dr., +8615680819215
About this study
Official title: Study on the Value of Musculoskeletal Cross-modal Imaging Assessment System in the Diagnosis and Prognosis of Sarcopenia in Lung Cancer Patients
- 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.
- 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.
- 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.
- Conditions
- Sarcopenia, Lung Cancer, Ultrasound
- Being tested
- ultrasound scan, CT/MRI scan
- Medical subject headings
- Sarcopenia, Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ultrasound scanDiagnostic test
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.
CT/MRI scanDiagnostic test
The patients with lung cancer who are scheduled to undergo radical resection of lung cancer are examined by abdominal CT/MRI.
| Study group | Role | What they receive |
|---|---|---|
| Lung cancer patients with sarcopenia | Not described Receives: Diagnostic Test: ultrasound scan; Diagnostic Test: CT/MRI scan | |
| Lung cancer patients without sarcopenia | Not described Receives: Diagnostic Test: ultrasound scan; Diagnostic Test: CT/MRI scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Death
Measured: 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.
Measured: Within 7 days after the surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2024
- Study start1 Nov 2023
- Primary completionNov 2027 (estimated)
- Study completionNov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SarcopeniaStudies of the same condition, open and under way.
- More trials run by West China HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 1,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- West China Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xinyi Tang, West China Hospital
- Investigators
- Xinyi Tang, Principal investigator, Department of Medical Ultrasound, West China Hospital, Sichuan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06327594
- Sponsor's protocol ID
- XTang-0002
- Status last verified
- Mar 2024
- First submitted
- 18 Mar 2024
- Last updated
- 25 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: By submitting an application to the project leader via email and obtaining approval from relevant hospital departments.
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on the Value of Musculoskeletal Cross-modal Imaging Assessment System in the Diagnosis and Prognosis of Sarcopenia in Lung Cancer Patients
- ClinicalTrials.gov ID
- NCT06327594
- Acronym / sponsor ID
- XTang-0002
- Conditions
- Sarcopenia, Lung Cancer, Ultrasound
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- West China HospitalUniversity, hospital or other
- Study start
- 1 Nov 2023 (actual)
- Primary completion
- Nov 2027 (estimated)
- Study completion
- Nov 2028 (estimated)
- First posted
- 25 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 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.
- 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.
- 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.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 40 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Hospitalized patients scheduled for radical resection of lung cancer.
Key inclusion criteria (3 listed)
- Hospitalized patients scheduled for radical resection of lung cancer.
- With a CT/MRI examination within 1 week.
- The compliance of examination was good.
Key exclusion criteria (4 listed)
- Amputated arm or leg.
- Severe oedema (oedema higher than knee level).
- Implantable pacemaker.
- Impaired consciousness, poor general health, or other reasons that would prevent the individual from completing the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ultrasound scanThe 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 | Lung cancer patients with sarcopenia, Lung cancer patients without sarcopenia |
| CT/MRI scanThe patients with lung cancer who are scheduled to undergo radical resection of lung cancer are examined by abdominal CT/MRI. | Diagnostic test | Lung cancer patients with sarcopenia, Lung cancer patients without sarcopenia |
Primary outcome
Death
Time frame: Within 2 years after the initial ultrasound examination
Perioperative complications
Time frame: Within 7 days after the surgery.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2024.
- Individual participant dataSharing planned: Undecided. By submitting an application to the project leader via email and obtaining approval from relevant hospital departments.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Xinyi Tang principal investigator
Department of Medical Ultrasound, West China Hospital, Sichuan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sarcopenia and Lung Cancer, run by West China Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xinyi Tang, Dr. (+8615680819215, tangxinyi1996@outlook.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Death (time frame: Within 2 years after the initial ultrasound examination). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2024.