SarcopeniaNCT05212285
Prognostic Value of Sarcopenia and Nutritional Status in Early-stage Non-small Cell Lung Cancer
An observational study of Sarcopenia and Non Small Cell Lung Cancer, run by Fudan University at 1 site in China.
Trial summary
Growing evidence has confirmed that the prognosis of lung cancer is not only related to the stage of disease, but also to the physiological and psychological situation of the patients. Malignant tumors are often associated with weakness and cachexia, leading to less physical activities and worse moods. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Sarcopenia, Non Small Cell Lung Cancer, Malnutrition
- What is being tested?
- Inbody 570, JAMAR Dynamometer and CT scan
- Type of treatment
- Medical device, Surgery or procedure
- How many people
- 469 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2020to 30 Apr 2025
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The patients with non-small cell lung cancer diagnosed by cytology or pathology meet the standards of clinical diagnosis and treatment guidelines for lung cancer of Chinese Medical Association (2018 Edition), and the TNM staging diagnosis of early-stage NSCLC meets the stage IA-IIIA.
Who may be able to join
- The patients with non-small cell lung cancer diagnosed by cytology or pathology meet the standards of clinical diagnosis and treatment guidelines for lung cancer of Chinese Medical Association (2018 Edition)
- TNM staging diagnosis of lung cancer meets the stage IA-IIIA
Who cannot join
- Severe heart failure, acute progressive pulmonary inflammation, acute liver and kidney dysfunction in recent 2 weeks
- Incomplete clinical and follow-up data or disagreement or inability to conduct regular follow-up CT imaging evaluation
- A history of other malignant tumors and related tumor chemotherapy within half year, and previous history of radiotherapy
- Unable to walk, fail to complete the walking test, and the risk of fall down
- Unable to complete BIA examination due to pacemaker implantation and other reasons
- Withdraw from the study for any reasons
Trial locations and contacts
1 site in 1 country.
China1 site
Huadong hospital, Fudan University
Shanghai, Shanghai Municipality, 200040
About this study
Official title: Prognostic Value of Sarcopenia and Nutritional Status in Early-stage Non-small Cell Lung Cancer (Stage IA to IIIA)
Growing evidence has confirmed that the prognosis of lung cancer is not only related to the stage of disease, but also to the physiological and psychological situation of the patients. Malignant tumors are often associated with weakness and cachexia, leading to less physical activities and worse moods. However, few studies that have attempted to investigate the impact of nutritional status on the prognosis of NSCLC. Existing applications of nutritional scoring systems in early-stage of NSCLC are very limited. Therefore, this study aims to observe the correlation between nutritional status and the prognosis of patients with early-stage NSCLC, to clarify the value in predicting the overall survival rate and progression-free survival rate of NSCLC patients, and to offer evidence for alleviating the social and economic burden of NSCLC.
Read the detailed description
The prognosis of lung cancer is not only related to the stage of disease, but also to the physiological and psychological situation of the patients. Malignant tumors are often associated with weakness and cachexia, leading to less physical activities and worse moods. However, few studies that have attempted to investigate the impact of nutritional status on the prognosis of NSCLC. Existing applications of nutritional scoring systems in early-stage of NSCLC are very limited. Therefore, this study aims to observe the correlation between nutritional status and the prognosis of patients with early-stage NSCLC, to clarify the value in predicting the overall survival rate and progression-free survival rate of NSCLC patients, and to offer evidence for alleviating the social and economic burden of NSCLC.
- Conditions
- Sarcopenia, Non Small Cell Lung Cancer, Malnutrition
- Being tested
- Inbody 570, JAMAR Dynamometer, CT scan
- Medical subject headings
- Sarcopenia, Carcinoma, Non-Small-Cell Lung, Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inbody 570Device
Bioelectrical Impedance Analysis with Inbody 570 (Inbody Co., Seoul, Korea) during each follow-up
JAMAR DynamometerDevice
Handgrip strength measurement using a JAMAR Dynamometer (JAMAR Co., Ltd., USA) during each follow-up
CT scanRadiation
Chest and abdominal CT scan during each follow-up
| Study group | Role | What they receive |
|---|---|---|
| Early-stage NSCLC with sarcopenia | Patients diagnosed with NSCLC meeting Stage IA-IIIA as well as sarcopenia by the enrollment Receives: Device: Inbody 570; Device: JAMAR Dynamometer; Radiation: CT scan | |
| Early-stage NSCLC without sarcopenia | Patients diagnosed with NSCLC meeting Stage IA-IIIA but without sarcopenia by the enrollment Receives: Device: Inbody 570; Device: JAMAR Dynamometer; Radiation: CT scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression Free Survival (PFS)
Due to the treatment frequency of lung cancer, we implemented the following follow-up schedule with actual follow-up completed for five years. Progression-free survival was measured from the date of diagnosis until the first occurrence of either: Objective tumor progression (confirmed by imaging per RECIST criteria), or death from any cause. whichever occurred first.
Measured: Follow-up were conducted every 2months during the first year and every 6 months for up to 5 years from enrollment. Progression-free survival was measured from the date of diagnosis until confirmed disease progression or death, whichever occurred first.
Secondary outcomes (1)
Overall Survival (OS)
Outcome of patient death from diagnosis to any cause or the final follow-up time
Measured: Follow-up were conducted every 2months during the first year and every 6 months for up to 5 years from enrollment. overall survival was measured from the date of diagnosis until death or the final follow-up time.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2022
- Study start1 Jan 2020
- Primary completion30 Apr 2025
- Study completion30 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for SarcopeniaStudies of the same condition, open and under way.
- More trials run by Fudan UniversityThe 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 469 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhijun Bao, Fudan University
- Investigators
- Ying-gang Zhu, MD, PhD, Principal investigator, Huadong Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05212285
- Sponsor's protocol ID
- POSE
- Status last verified
- Jul 2025
- First submitted
- 13 Jan 2022
- Last updated
- 1 Aug 2025
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prognostic Value of Sarcopenia and Nutritional Status in Early-stage Non-small Cell Lung Cancer (Stage IA to IIIA)
- ClinicalTrials.gov ID
- NCT05212285
- Acronym / sponsor ID
- POSE
- Conditions
- Sarcopenia, Non Small Cell Lung Cancer, Malnutrition
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 469 participants (actual)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 30 Apr 2025 (actual)
- Study completion
- 30 Apr 2025 (actual)
- First posted
- 28 Jan 2022 (actual)
- Results
- Posted 1 Aug 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Growing evidence has confirmed that the prognosis of lung cancer is not only related to the stage of disease, but also to the physiological and psychological situation of the patients. Malignant tumors are often associated with weakness and cachexia, leading to less physical activities and worse moods. However, few studies that have attempted to investigate the impact of nutritional status on the prognosis of NSCLC. Existing applications of nutritional scoring systems in early-stage of NSCLC are very limited. Therefore, this study aims to observe the correlation between nutritional status and the prognosis of patients with early-stage NSCLC, to clarify the value in predicting the overall survival rate and progression-free survival rate of NSCLC patients, and to offer evidence for alleviating the social and economic burden of NSCLC.
Detailed description
The prognosis of lung cancer is not only related to the stage of disease, but also to the physiological and psychological situation of the patients. Malignant tumors are often associated with weakness and cachexia, leading to less physical activities and worse moods. However, few studies that have attempted to investigate the impact of nutritional status on the prognosis of NSCLC. Existing applications of nutritional scoring systems in early-stage of NSCLC are very limited. Therefore, this study aims to observe the correlation between nutritional status and the prognosis of patients with early-stage NSCLC, to clarify the value in predicting the overall survival rate and progression-free survival rate of NSCLC patients, and to offer evidence for alleviating the social and economic burden of NSCLC.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Early-stage NSCLC with sarcopenia | – | Device: Inbody 570, Device: JAMAR Dynamometer, Radiation: CT scanPatients diagnosed with NSCLC meeting Stage IA-IIIA as well as sarcopenia by the enrollment |
| Early-stage NSCLC without sarcopenia | – | Device: Inbody 570, Device: JAMAR Dynamometer, Radiation: CT scanPatients diagnosed with NSCLC meeting Stage IA-IIIA but without sarcopenia by the enrollment |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The patients with non-small cell lung cancer diagnosed by cytology or pathology meet the standards of clinical diagnosis and treatment guidelines for lung cancer of Chinese Medical Association (2018 Edition), and the TNM staging diagnosis of early-stage NSCLC meets the stage IA-IIIA.
Key inclusion criteria (2 listed)
- The patients with non-small cell lung cancer diagnosed by cytology or pathology meet the standards of clinical diagnosis and treatment guidelines for lung cancer of Chinese Medical Association (2018 Edition)
- TNM staging diagnosis of lung cancer meets the stage IA-IIIA
Key exclusion criteria (6 listed)
- Severe heart failure, acute progressive pulmonary inflammation, acute liver and kidney dysfunction in recent 2 weeks
- Incomplete clinical and follow-up data or disagreement or inability to conduct regular follow-up CT imaging evaluation
- A history of other malignant tumors and related tumor chemotherapy within half year, and previous history of radiotherapy
- Unable to walk, fail to complete the walking test, and the risk of fall down
- Unable to complete BIA examination due to pacemaker implantation and other reasons
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 |
|---|---|---|
| Inbody 570Bioelectrical Impedance Analysis with Inbody 570 (Inbody Co., Seoul, Korea) during each follow-up | Device | Early-stage NSCLC with sarcopenia, Early-stage NSCLC without sarcopenia |
| JAMAR DynamometerHandgrip strength measurement using a JAMAR Dynamometer (JAMAR Co., Ltd., USA) during each follow-up | Device | Early-stage NSCLC with sarcopenia, Early-stage NSCLC without sarcopenia |
| CT scanChest and abdominal CT scan during each follow-up | Radiation | Early-stage NSCLC with sarcopenia, Early-stage NSCLC without sarcopenia |
Primary outcome
Progression Free Survival (PFS)
Time frame: Follow-up were conducted every 2months during the first year and every 6 months for up to 5 years from enrollment. Progression-free survival was measured from the date of diagnosis until confirmed disease progression or death, whichever occurred first.
Due to the treatment frequency of lung cancer, we implemented the following follow-up schedule with actual follow-up completed for five years. Progression-free survival was measured from the date of diagnosis until the first occurrence of either: Objective tumor progression (confirmed by imaging per RECIST criteria), or death from any cause. whichever occurred first.
1 secondary outcome
Overall Survival (OS)
Time frame: Follow-up were conducted every 2months during the first year and every 6 months for up to 5 years from enrollment. overall survival was measured from the date of diagnosis until death or the final follow-up time.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Ying-gang Zhu, MD, PhD principal investigator
Huadong Hospital
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 Non Small Cell Lung Cancer, run by Fudan University 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 2 inclusion and 6 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: finished, as of the sponsor's last update on 1 Aug 2025. 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?
Yes. Results are posted in the registry (first posted 1 Aug 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression Free Survival (PFS) (time frame: Follow-up were conducted every 2months during the first year and every 6 months for up to 5 years from enrollment. Progression-free survival was measured from the date of diagnosis until confirmed disease progression or death, whichever occurred first.). 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 1 Aug 2025.