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Hepatocellular CarcinomaNCT05448222

Effect of Sarcopenia on Hepatocellular Carcinoma(HCC) After Systemic Therapies

An observational study of Hepatocellular Carcinoma and Sarcopenia, run by First Affiliated Hospital of Wenzhou Medical University at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Sarcopenia is associated with the prognosis of HCC and cholangiocarcinoma. But there has been rare study focusing on the effect of sarcopenia on the prognosis of HCC treated with systemic therapy, such as interventional therapy, targeted therapy, chemotherapy and immunotherapy and so on. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Hepatocellular Carcinoma, Sarcopenia
What is being tested?
Diagnostic Test: gait speed; ct scan; grip strength and chair stand test
How many people
300 participants
Where
1 siteChina
Study dates
1 Jul 2022to 1 Dec 2024
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 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients with clinical diagnosis of hepatocellular carcinoma admitted to the first affiliated hospital of wenzhou medical university and received standard tests and questionnaires.

Who may be able to join

  • clinical diagnosis of hepatocellular carcinoma
  • No cancer other than liver cancer has been diagnosed
  • Age ≥18 years
  • child-pugh score≤7

Who cannot join

  • uncompleted standard tests and questionnaires
  • received other therapies
  • Patients who had other 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)
  • lost follow-up

Trial locations and contacts

1 site in 1 country.

China1 site

  • Gang Chen

    Wenzhou, Zhejiang, 325000

Other trials in China

About this study

Official title: Effect of Sarcopenia on the Efficacy and Prognosis of HCC Treated With Systemic Therapies

Sarcopenia is associated with the prognosis of HCC and cholangiocarcinoma. But there has been rare study focusing on the effect of sarcopenia on the prognosis of HCC treated with systemic therapy, such as interventional therapy, targeted therapy, chemotherapy and immunotherapy and so on.

Read the detailed description

By tracking the short-term and long-term results of HCC patients treated with systemic therapy,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 systemic treatments was explored, so as to improve people's awareness of sarcopenia and pay attention to its prevention and treatment.All implementation details are based on the newest EuropeanWorking Group on Sarcopenia in Older People(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, the differences were analyzed and the relationship between sarcopenia and prognosis of systemic treatments was explored.

Being tested
Diagnostic Test: gait speed; ct scan; grip strength and chair stand test
Keywords
hepatocellular carcinoma, sarcopenia, prognosis, adverse events, systemic therapy
Medical subject headings
Carcinoma, Hepatocellular, Sarcopenia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Diagnostic Test: 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.

  1. complications

    The complications were classified according to the Clavien-Dindo classification, such as hypertension, fever, abdominal pain and so on.

    Measured: 3 months

  2. overall survival

    Overall survival was defined as the time from initiation of lenvatinib to death for any reason.

    Measured: 2 years

  3. progression free survival

    Progression free survival was defined as the time from initiation of lenvatinib to first progression or death.

    Measured: 2 years

Secondary outcomes (2)

  1. Hospital stay

    The time that patients spent in the hospital was recorded.

    Measured: 3 months

  2. Hospital cost

    Hospital cost that patients spent was recorded.

    Measured: 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Jul 2022
  2. Study start1 Jul 2022
  3. Primary completion1 Dec 2024 (estimated)
  4. Study completion1 Dec 2024 (estimated)

Resources

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
Prospective
Enrolment
300 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05448222
Sponsor's protocol ID
sarcopenia and liver cancer
Status last verified
Sep 2023
First submitted
1 Jul 2022
Last updated
13 Sep 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Smith C, Woessner MN, Sim M, Levinger I. Sarcopenia definition: Does it really matter? Implications for resistance training. Ageing Res Rev. 2022 Jun;78:101617. doi: 10.1016/j.arr.2022.101617. Epub 2022 Apr 1.

    PubMed 35378297

  • Leong DP, Teo KK, Rangarajan S, Lopez-Jaramillo P, Avezum A Jr, Orlandini A, Seron P, Ahmed SH, Rosengren A, Kelishadi R, Rahman O, Swaminathan S, Iqbal R, Gupta R, Lear SA, Oguz A, Yusoff K, Zatonska K, Chifamba J, Igumbor E, Mohan V, Anjana RM, Gu H, Li W, Yusuf S; Prospective Urban Rural Epidemiology (PURE) Study investigators. Prognostic value of grip strength: findings from the Prospective Urban Rural Epidemiology (PURE) study. Lancet. 2015 Jul 18;386(9990):266-73. doi: 10.1016/S0140-6736(14)62000-6. Epub 2015 May 13.

    PubMed 25982160

  • Chen LK, Woo J, Assantachai P, Auyeung TW, Chou MY, Iijima K, Jang HC, Kang L, Kim M, Kim S, Kojima T, Kuzuya M, Lee JSW, Lee SY, Lee WJ, Lee Y, Liang CK, Lim JY, Lim WS, Peng LN, Sugimoto K, Tanaka T, Won CW, Yamada M, Zhang T, Akishita M, Arai H. Asian Working Group for Sarcopenia: 2019 Consensus Update on Sarcopenia Diagnosis and Treatment. J Am Med Dir Assoc. 2020 Mar;21(3):300-307.e2. doi: 10.1016/j.jamda.2019.12.012. Epub 2020 Feb 4.

    PubMed 32033882

  • Kobayashi A, Kaido T, Hamaguchi Y, Okumura S, Shirai H, Yao S, Kamo N, Yagi S, Taura K, Okajima H, Uemoto S. Impact of Sarcopenic Obesity on Outcomes in Patients Undergoing Hepatectomy for Hepatocellular Carcinoma. Ann Surg. 2019 May;269(5):924-931. doi: 10.1097/SLA.0000000000002555.

    PubMed 29064889

  • Dasarathy S, Merli M. Sarcopenia from mechanism to diagnosis and treatment in liver disease. J Hepatol. 2016 Dec;65(6):1232-1244. doi: 10.1016/j.jhep.2016.07.040. Epub 2016 Aug 8.

    PubMed 27515775

Questions about this trial

What is this clinical trial studying?

An observational study of Hepatocellular Carcinoma 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 4 inclusion and 5 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 13 Sep 2023. 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?

complications (time frame: 3 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05448222, which also lists 5 linked publications.

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 13 Sep 2023.

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