Comparison of Serum Myokine Dosages and Imaging Methods in the Evaluation of Sarcopenia in Patients With Hepatocellular Carcinoma (Myomachia)

November 25, 2024 updated by: CHU de Reims
It is known that some substances present in the blood, called 'myokines,' influence muscle loss. Some may accelerate this loss, while others may prevent it. Inflammatory substances in the blood can also contribute to muscle loss. Sarcopenia is assessed by an imaging technique called 'Skeletal Muscle Mass Index (SMI)' to measure muscle mass. This analysis can be done from radiological examinations. Sarcopenia has a serious impact on patients with hepatocellular carcinoma. It increases the risk of death, cancer recurrence, and decreases the response to treatments. Therefore, the investigators want to determine if blood tests for myokines obtained by simple blood draw can improve the assessment of sarcopenia in this specific setting.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Background:

Sarcopenia, which is a reduction of muscle mass and function, frequently occurs from the age of 40 and is exacerbated by diseases such as cirrhosis, chronic inflammation, and cancer. It is well established that sarcopenia impairs quality of life and promotes the occurrence of complications. Myostatin, a muscle hormone (myokine), contributes to sarcopenia by promoting muscle degradation. Conversely, follistatin, an antagonist of myostatin, may play a role in maintaining muscle mass and protein synthesis. Irisin, another myokine, can protect against muscle atrophy and improve metabolism. Inflammatory cytokines like TNF-α and IL-6 can also contribute to sarcopenia by promoting muscle degradation. To evaluate sarcopenia in patients with cirrhosis and cancer, the most commonly used method is the calculation of the Skeletal Muscle Index (SMI) at the third lumbar vertebra (L3 SMI: Total Muscle Surface at L3 in cm²/ Height in m²). Other methods can also be used, but are susceptible to being influenced by water retention, particularly in cirrhotic patients. In patients with cirrhosis, sarcopenia negatively impacts quality of life and is associated with an increased risk of serious complications. In patients with hepatocellular carcinoma (HCC), it increases mortality, tumor recurrence, and reduces the response to treatments. Thus, its assessment and management are essential to improve the quality of life and prognosis of these patients. The validation of biological diagnostic criteria for sarcopenia would facilitate diagnosis and ensure follow-up without resorting to repetitive imaging.

Materials and Methods:

Type of study: Prospective validation study of a diagnostic method

Judgment criteria:

  • Serum concentrations of myostatin, follistatin, and irisin
  • Muscle surface calculated at L3 and parameterized according to height (L3 SMI)
  • Muscle strength assessed by dynamometry

Investigation plan:

  1. Screening of Patient after discussion in Multidisciplinary Liver Cancer Board
  2. Proposal of the study during the announcement consultation after RCP.
  3. Blood sampling during standard pre-therapeutic care and dynamometry measurement
  4. Retrieval of scanographic imaging and calculation of the L3 SMI index
  5. Blood dosages of myokines
  6. Statistical analyses

Schedule:

  • April 2024-July 2024: CPP evaluation
  • August 2024-July 2025: Inclusion period.
  • August 2024-July 2025: Radiological analyses (in parallel with the inclusions). Selection of available imagery, extraction of key images. Analysis of muscle mass and calculation of the L3 SMI index.
  • August 2024-July 2025: Biological analyses (in parallel with the radiological analyses). Measurement of blood concentrations of myokines.
  • August 2025-April 2026: Statistical analyses and article writing.

Expected Results and Prospects:

The current priority og investigators is to validate rapid and effective serum markers to facilitate the early diagnosis and clinical follow-up of sarcopenia in patients with hepatocellular carcinoma. In the long term, the goal is to implement early interventions aimed at mitigating the effects of sarcopenia. These serum markers could improve the management of liver diseases and cancers as key prognostic factors. The results of this study will also contribute to a better pathophysiological understanding of sarcopenia in these patients.

Study Type

Interventional

Enrollment (Estimated)

139

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion criteria:

  • New diagnosis of HCC made by radiology and/or histopathology according to EASL criteria, regardless of the degree of hepatic fibrosis (METAVIR F0-F4)
  • Availability of a pre-therapeutic three-phase contrast-enhanced abdominal-pelvic CT scan.

Non-inclusion criteria:

  • Presence of an active cancer other than HCC
  • Uncontrolled HIV infection.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Patients with hepatocellular carcinoma
Other: Dynamometry measurement, myokine dosing, sarcopenia calculation
Blood sampling during standard pre-therapeutic care (at the same time with a standard blood testing) and dynamometry measurement. Retrieval of scanographic imaging and calculation of the L3 SMI index

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Determine if serum myokines measured in patients with HCC are correlated with muscle mass index assessed by standard scanographic technique.
Time Frame: Day 1
Analysis of correlation between serum myokines measured in patients with HCC and muscle mass index assessed by standard scanographic technique
Day 1

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Determine if serum myokines measured in patients with HCC are correlated with muscle strength assessed by dynamometry
Time Frame: Day 1
Analysis of correlation between serum myokines measured in patients with HCC and Muscle strength assessed by dynamometry
Day 1
Determine if inflammatory cytokines (IL6, TNFα) measured in patients with HCC are correlated with muscle mass index assessed by the standard scanographic technique
Time Frame: Day 1
Analysis of correlation between inflammatory cytokines (IL6, TNFα) measured in patients with HCC and muscle mass index assessed by the standard scanographic technique
Day 1
Determine the serum myokine concentration threshold for the diagnosis of sarcopenia defined by an L3 SMI < 50 cm2/m2 in men
Time Frame: Day 1
Analysis of correlation between serum myokines thresholds in patients with HCC and sarcopenia defined by an L3 SMI < 50 cm^2/m^2 in men
Day 1
Determine the serum myokine concentration threshold for the diagnosis of sarcopenia defined by an L3 SMI < 39 cm2/m2 in women
Time Frame: Day 1
Analysis of correlation between serum myokines thresholds in patients with HCC and sarcopenia defined by an L3 SMI < 39 cm^2/m^2 in women
Day 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

CHU de Reims

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 22, 2024

Primary Completion (Estimated)

November 22, 2025

Study Completion (Estimated)

May 22, 2026

Study Registration Dates

First Submitted

June 20, 2024

First Submitted That Met QC Criteria

June 20, 2024

First Posted (Actual)

June 26, 2024

Study Record Updates

Last Update Posted (Estimated)

November 26, 2024

Last Update Submitted That Met QC Criteria

November 25, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PA24055

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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