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Influence of Sarcopenia in Hepatocellular Carcinoma Patients

NCT ID: NCT06177496

Last Updated: 2023-12-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

600 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-02-01

Study Completion Date

2024-12-01

Brief Summary

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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.

Detailed Description

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Conditions

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Sarcopenia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Group A

HCC patients underwent local ablation

local ablation

Intervention Type PROCEDURE

treatment of HCC

Group B

HCC patients underwent TACE

TACE

Intervention Type PROCEDURE

treatment of HCC

Group C

HCC patients received sorafenib

Sorafenib

Intervention Type DRUG

treatment of HCC

Interventions

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local ablation

treatment of HCC

Intervention Type PROCEDURE

TACE

treatment of HCC

Intervention Type PROCEDURE

Sorafenib

treatment of HCC

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Clinical diagnosis of hepatocellular carcinoma.
2. Treatment-naive patients who underwent local ablation, TACE or sorafenib as a primary treatment .

Exclusion Criteria

1. Use of other another HCC treatment modality e.g., resection.
2. Use of combined treatments e.g., simultaneous use of embolic therapy with ablation.
3. Patients with recurrent HCC.
4. Patients with secondaries from extra-hepatic primary tumors.
5. Incomplete data at the diagnosis, treatment or follow up time-points.
6. Loss of patients follow up.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sohag University

OTHER

Sponsor Role lead

Responsible Party

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Mohamed Abdelwahab Mohamed

Lecturer of Tropical Medicine and Gastroenterology

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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Soh-Med-23-09-11PD

Identifier Type: -

Identifier Source: org_study_id