Comparison of Serum Myokine Dosages and Imaging Methods in the Evaluation of Sarcopenia in Patients With Hepatocellular Carcinoma
Myomachia
1 other identifier
interventional
139
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Nov 2024
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 20, 2024
CompletedFirst Posted
Study publicly available on registry
June 26, 2024
CompletedStudy Start
First participant enrolled
November 22, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 22, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
May 22, 2026
ExpectedNovember 26, 2024
November 1, 2024
1 year
June 20, 2024
November 25, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Determine if serum myokines measured in patients with HCC are correlated with muscle mass index assessed by standard scanographic technique.
Analysis of correlation between serum myokines measured in patients with HCC and muscle mass index assessed by standard scanographic technique
Day 1
Secondary Outcomes (4)
Determine the serum myokine concentration threshold for the diagnosis of sarcopenia defined by an L3 SMI < 50 cm2/m2 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
Day 1
Determine if serum myokines measured in patients with HCC are correlated with 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
Day 1
Study Arms (1)
Patients with hepatocellular carcinoma
EXPERIMENTALInterventions
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
Eligibility Criteria
You may qualify if:
- 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.
- Presence of an active cancer other than HCC
- Uncontrolled HIV infection.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- CHU de Reimslead
Study Sites (1)
Damien JOLLY
Reims, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 20, 2024
First Posted
June 26, 2024
Study Start
November 22, 2024
Primary Completion
November 22, 2025
Study Completion (Estimated)
May 22, 2026
Last Updated
November 26, 2024
Record last verified: 2024-11