SarcopeniaNCT06177496
Influence of Sarcopenia in Hepatocellular Carcinoma Patients
An observational study of Sarcopenia, run by Sohag University.
Trial summary
Liver cancer poses a major threat to the global cancer burden, and the number of deaths is estimated to be more than one million annually by 2030. Locoregional therapies such as transarterial chemoembolization (TACE), transarterial radioembolization (TARE), and radiation are associated with improved survival and… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sarcopenia
- What is being tested?
- local ablation, TACE and Sorafenib
- Type of treatment
- Surgery or procedure
- How many people
- 600 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2024to 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Treatment-naive hepatocellular carcinoma patients who underwent local ablation, TACE or sorafenib as a primary treatment.
Who may be able to join
- Clinical diagnosis of hepatocellular carcinoma.
- Treatment-naive patients who underwent local ablation, TACE or sorafenib as a primary treatment .
Who cannot join
- Use of other another HCC treatment modality e.g., resection.
- Use of combined treatments e.g., simultaneous use of embolic therapy with ablation.
- Patients with recurrent HCC.
- Patients with secondaries from extra-hepatic primary tumors.
- Incomplete data at the diagnosis, treatment or follow up time-points.
- Loss of patients follow up.
About this study
Official title: Influence of Sarcopenia on Mortality and Disease Progression in Hepatocellular Carcinoma Treated With Ablation, Embolization and Sorafenib
Liver cancer poses a major threat to the global cancer burden, and the number of deaths is estimated to be more than one million annually by 2030. Locoregional therapies such as transarterial chemoembolization (TACE), transarterial radioembolization (TARE), and radiation are associated with improved survival and quality of life for patients with unresectable HCC [Couri and Pillai, 2019]. However, curative therapies or locoregional therapies are not applicable to approximately 50% of HCC cases who are diagnosed at an advanced stage and have progression with transarterial therapies [Park et al., 2015]. For these patients, sorafenib, lenvatinib, and atezolizumab combined with bevacizumab have been approved as the first-line systemic therapy [Fan et al., 2022].
Sarcopenia is a progressive and generalized skeletal muscle disease characterized by accelerated loss of muscle mass and function [Cruz-Jentoft and Sayer, 2019]. It has been associated with higher mortality among the general population and patients with cancer. This study aims to assess the possible role of sarcopenia in predicting the outcome of HCC patients following a variety of treatments including local ablation, TACE and sorafenib.
- Conditions
- Sarcopenia
- Medical subject headings
- Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
local ablationProcedure or surgery
treatment of HCC
TACEProcedure or surgery
treatment of HCC
SorafenibDrug
treatment of HCC
| Study group | Role | What they receive |
|---|---|---|
| Group A | HCC patients underwent local ablation Receives: Procedure: local ablation | |
| Group B | HCC patients underwent TACE Receives: Procedure: TACE | |
| Group C | HCC patients received sorafenib Receives: Drug: Sorafenib |
What is being measured
The primary outcome is the main question the study is designed to answer.
overall survival
time from treatment till death or last contact
Measured: for at least 1 year from the treatment
Secondary outcomes (2)
Recurrence-free survival
time from HCC treatment to tumor relapse (identified by imaging) or last contact
Measured: for at least 1 year from the treatment
Progression-free survival
time from HCC treatment to tumor progression (identified by imaging) or last contact
Measured: for at least 1 year from the treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2023
- Study start1 Feb 2024 (estimated)
- Primary completion1 Jun 2024 (estimated)
- Study completion1 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SarcopeniaStudies of the same condition, open and under way.
- More trials run by Sohag 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Abdelwahab Mohamed, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06177496
- Sponsor's protocol ID
- Soh-Med-23-09-11PD
- Status last verified
- Dec 2023
- First submitted
- 27 Nov 2023
- Last updated
- 20 Dec 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Sarcopenia on Mortality and Disease Progression in Hepatocellular Carcinoma Treated With Ablation, Embolization and Sorafenib
- ClinicalTrials.gov ID
- NCT06177496
- Acronym / sponsor ID
- Soh-Med-23-09-11PD
- Conditions
- Sarcopenia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 1 Feb 2024 (estimated)
- Primary completion
- 1 Jun 2024 (estimated)
- Study completion
- 1 Dec 2024 (estimated)
- First posted
- 20 Dec 2023 (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.
Liver cancer poses a major threat to the global cancer burden, and the number of deaths is estimated to be more than one million annually by 2030. Locoregional therapies such as transarterial chemoembolization (TACE), transarterial radioembolization (TARE), and radiation are associated with improved survival and quality of life for patients with unresectable HCC [Couri and Pillai, 2019]. However, curative therapies or locoregional therapies are not applicable to approximately 50% of HCC cases who are diagnosed at an advanced stage and have progression with transarterial therapies [Park et al., 2015]. For these patients, sorafenib, lenvatinib, and atezolizumab combined with bevacizumab have been approved as the first-line systemic therapy [Fan et al., 2022].
Sarcopenia is a progressive and generalized skeletal muscle disease characterized by accelerated loss of muscle mass and function [Cruz-Jentoft and Sayer, 2019]. It has been associated with higher mortality among the general population and patients with cancer. This study aims to assess the possible role of sarcopenia in predicting the outcome of HCC patients following a variety of treatments including local ablation, TACE and sorafenib.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group A | – | Procedure: local ablationHCC patients underwent local ablation |
| Group B | – | Procedure: TACEHCC patients underwent TACE |
| Group C | – | Drug: SorafenibHCC patients received sorafenib |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Treatment-naive hepatocellular carcinoma patients who underwent local ablation, TACE or sorafenib as a primary treatment.
Key inclusion criteria (2 listed)
- Clinical diagnosis of hepatocellular carcinoma.
- Treatment-naive patients who underwent local ablation, TACE or sorafenib as a primary treatment .
Key exclusion criteria (6 listed)
- Use of other another HCC treatment modality e.g., resection.
- Use of combined treatments e.g., simultaneous use of embolic therapy with ablation.
- Patients with recurrent HCC.
- Patients with secondaries from extra-hepatic primary tumors.
- Incomplete data at the diagnosis, treatment or follow up time-points.
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 |
|---|---|---|
| local ablationtreatment of HCC | Procedure or surgery | Group A |
| TACEtreatment of HCC | Procedure or surgery | Group B |
| Sorafenibtreatment of HCC | Drug | Group C |
Primary outcome
overall survival
Time frame: for at least 1 year from the treatment
time from treatment till death or last contact
2 secondary outcomes
Recurrence-free survival
Time frame: for at least 1 year from the treatment
Progression-free survival
Time frame: for at least 1 year from the treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2023.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Sarcopenia, run by Sohag University.
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: status not confirmed, as of the sponsor's last update on 20 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
overall survival (time frame: for at least 1 year from the treatment). 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 20 Dec 2023.