Liver CancerNCT05339919
Relationship Between Liver Cancer and Sarcopenia
An observational study of Liver Cancer and Sarcopenia, run by First Affiliated Hospital of Wenzhou Medical University at 1 site in China.
Trial summary
By tracking the short-term and long-term results of patients after hepatectomy, the difference of short-term results between patients with sarcopenia and patients without sarcopenia was analyzed, and the correlation between sarcopenia and short-term and long-term results of patients after hepatectomy was explored, so… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Cancer, Sarcopenia
- What is being tested?
- gait speed; ct scan;grip strength and chair stand test
- How many people
- 1,200 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2020to 28 Aug 2025
- How long will I take part?
- 10 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with preoperative clinical diagnosis of liver cancer admitted to the hepatobiliary surgery department and received standard tests and questionnaires.
Who may be able to join
- Patients with preoperative clinical diagnosis of liver cancer
- No cancer other than liver cancer has been diagnosed
- Age ≥18 years
Who cannot join
- Patients who could not complete the standard tests and questionnaires
- Patients who did not accept liver resection after evaluation of treatment plan
- Patients who had other concomitant preoperative causes of muscle weakness (injury, fracture, stroke, etc.)
- Patients who missing CT data or CT scan did not reach the level of the third lumbar vertebra (L3)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Sarcopenia on Hepatocellular Carcinoma After Hepatectomy
By tracking the short-term and long-term results of patients after hepatectomy, the difference of short-term results between patients with sarcopenia and patients without sarcopenia was analyzed, and the correlation between sarcopenia and short-term and long-term results of patients after hepatectomy was explored, so as to improve people's awareness of sarcopenia and pay attention to its prevention and treatment.
Read the detailed description
All implementation details are based on the newest EWGSOP definition. The investigators consecutively admitted patients the questionnaire and evaluated the assessment of muscle strength (grip strength test and chair stand test), muscle quantity (L3 plane total skeletal muscle area) and physical performance (gait test) following the F-A-C-S approach, to confirm patients with sarcopenia accurately. And by tracking the short-term and long-term outcomes of patients after hepatectomy, the differences were analyzed and the relationship between sarcopenia and liver cancer was explored.
- Conditions
- Liver Cancer, Sarcopenia
- Being tested
- gait speed; ct scan;grip strength and chair stand test
- Keywords
- Sarcopenia, Liver cancer, Hepatectomy, Short-term outcomes, Long-term outcomes
- Medical subject headings
- Liver Neoplasms, Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
gait speed; ct scan;grip strength and chair stand testDiagnostic test
The chair stand test was administered, and the time required for the patient to stand five times from a sitting position without using the arms was measured. CT scan was to scan the patient's third lumbar level. For the gait speed test, the time that patients spent walking 8 meters on a flat indoor floor at usual walking speed was measured.Grip strength test:the dominant hand and the nondominant hand were measured twice intermittently (kg), and the average value of 4 values was obtained.
What is being measured
The primary outcome is the main question the study is designed to answer.
Short-term postoperative results
Postoperative complications；90 days readmission rate
Measured: 3 months
Long-term results after operation
Overall survival; Disease free survival
Measured: 10 years
Secondary outcomes (2)
Postoperative hospitalization time
Time window from the day of operation to the day of discharge.
Measured: 2 months
Hospitalization expenses
All hospitalization expenses, including drug expenses, operation expenses, anesthesia expenses, nursing expenses and other expenses.
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2022
- Study start1 May 2020
- Primary completion11 Aug 2021
- Study completion28 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver CancerStudies of the same condition, open and under way.
- More trials run by First Affiliated Hospital of Wenzhou Medical 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
- 1,200 participants (estimated)
- Target duration
- 10 Years
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Qilu Hospital of Shandong University, The Second Hospital of Shandong University
- Responsible party
- Principal investigator, Gang Chen, MD, First Affiliated Hospital of Wenzhou Medical University
- Investigators
- Gang Chen, M.D., Principal investigator, First Affiliated Hospital of Wenzhou Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05339919
- Sponsor's protocol ID
- sarcopenia
- Status last verified
- Jun 2022
- First submitted
- 9 Apr 2022
- Last updated
- 15 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- 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 15 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Sarcopenia on Hepatocellular Carcinoma After Hepatectomy
- ClinicalTrials.gov ID
- NCT05339919
- Acronym / sponsor ID
- sarcopenia
- Conditions
- Liver Cancer, Sarcopenia
- Keywords
- Sarcopenia, Liver cancer, Hepatectomy, Short-term outcomes, Long-term outcomes
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,200 participants (estimated)
- Lead sponsor
- First Affiliated Hospital of Wenzhou Medical UniversityUniversity, hospital or other
- Collaborators
- Qilu Hospital of Shandong University, The Second Hospital of Shandong University
- Study start
- 1 May 2020 (actual)
- Primary completion
- 11 Aug 2021 (actual)
- Study completion
- 28 Aug 2025 (estimated)
- First posted
- 21 Apr 2022 (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.
By tracking the short-term and long-term results of patients after hepatectomy, the difference of short-term results between patients with sarcopenia and patients without sarcopenia was analyzed, and the correlation between sarcopenia and short-term and long-term results of patients after hepatectomy was explored, so as to improve people's awareness of sarcopenia and pay attention to its prevention and treatment.
Detailed description
All implementation details are based on the newest EWGSOP definition. The investigators consecutively admitted patients the questionnaire and evaluated the assessment of muscle strength (grip strength test and chair stand test), muscle quantity (L3 plane total skeletal muscle area) and physical performance (gait test) following the F-A-C-S approach, to confirm patients with sarcopenia accurately. And by tracking the short-term and long-term outcomes of patients after hepatectomy, the differences were analyzed and the relationship between sarcopenia and liver cancer was explored.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 10 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with preoperative clinical diagnosis of liver cancer admitted to the hepatobiliary surgery department and received standard tests and questionnaires.
Key inclusion criteria (3 listed)
- Patients with preoperative clinical diagnosis of liver cancer
- No cancer other than liver cancer has been diagnosed
- Age ≥18 years
Key exclusion criteria (4 listed)
- Patients who could not complete the standard tests and questionnaires
- Patients who did not accept liver resection after evaluation of treatment plan
- Patients who had other concomitant preoperative causes of muscle weakness (injury, fracture, stroke, etc.)
- Patients who missing CT data or CT scan did not reach the level of the third lumbar vertebra (L3)
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 |
|---|---|---|
| gait speed; ct scan;grip strength and chair stand testThe chair stand test was administered, and the time required for the patient to stand five times from a sitting position without using the arms was measured. CT scan was to scan the patient's third lumbar level. For the gait speed test, the time that patients spent walking 8 meters on a flat indoor floor at usual walking speed was measured.Grip strength test:the dominant hand and the nondominant hand were measured twice intermittently (kg), and the average value of 4 values was obtained. | Diagnostic test | – |
Primary outcome
Short-term postoperative results
Time frame: 3 months
Postoperative complications；90 days readmission rate
Long-term results after operation
Time frame: 10 years
Overall survival; Disease free survival
2 secondary outcomes
Postoperative hospitalization time
Time frame: 2 months
Hospitalization expenses
Time frame: 2 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2022.
- 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.
Gang Chen, M.D. principal investigator
First Affiliated Hospital of Wenzhou Medical 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 Liver Cancer and Sarcopenia, run by First Affiliated Hospital of Wenzhou Medical 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 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: status not confirmed, as of the sponsor's last update on 15 Jun 2022. 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?
Results are not available in the source record.
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?
Short-term postoperative results (time frame: 3 months). 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 15 Jun 2022.