Sarcopenia and Systemic Therapy in HCC

NCT06805552 | Recruiting

• 1 other identifier: Sarco HCC
• Study Type: observational
• Target: 270
• Locations: 1 country
• Sites: 1

Brief Summary

This is a multi-center, retrospective observational study in patients with liver cancer (HCC) to assess the impact of sarcopenia (muscle loss) on the prognosis, duration, and tolerance of systemic treatment.

Conditions

HCC - Hepatocellular Carcinoma

Keywords

Hepatocellular Carcinoma; Sarcopenia; HCC systemic therapy

Outcome Measures

Primary Outcomes (1)

• Prognostic role of Sarcopenia in HCC patient's survival

  Evaluation of the prognostic role of sarcopenia in the survival of patients affected by HCC in liver cirrhosis and candidates for systemic treatment. Possible development of a specific classification system for the risk of death.

  From January 2008 to April 2021

Secondary Outcomes (1)

• Role of Sarcopenia in HCC systemic therapy tolerability

  From January 2008 to April 2021

Study Arms (1)

HCC Patients

Patients with hepatocellular carcinoma treated with systemic therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients affected with Hepatocellular Carcinoma

You may qualify if:

• Patients aged ≥18 years.
• Diagnosis of hepatocellular carcinoma based on histological and/or radiological results as defined by the European Association for the Study of the Liver (EASL) and the American Association for the Study of Liver Diseases (AASLD). The staging of hepatocellular carcinoma was obtained through contrast-enhanced liver CT and/or MRI.
• Patients with advanced (BCLC-C) or intermediate (BCLC-B) stage hepatocellular carcinoma, or patients with early-stage (BCLC-A) hepatocellular carcinoma who have not responded to previous locoregional ablative treatments and/or liver resection.
• Treatment with TKIs according to the indications and prescription criteria defined by AIFA, with no requirement to reach a minimum treatment period.
• Availability of a CT scan performed within no more than 8 weeks prior to the start of TKI therapy.
• \- Obtaining written informed consent.

You may not qualify if:

• None

Sponsors & Collaborators

• IRCCS Azienda Ospedaliero-Universitaria di Bologna: lead
• Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico: collaborator

Study Sites (1)

IRCCS AOUBO Policlinico di S.Orsola

Bologna, 40138, Italy

RECRUITING

MeSH Terms

Conditions

Carcinoma, Hepatocellular; Sarcopenia

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases; Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Central Study Contacts

Dr. Maurizio Biselli Principal Investigator, MD

CONTACT

+39 051 2142928; maurizio.biselli@unibo.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 28, 2025
• First Posted: February 3, 2025
• Study Start: October 19, 2022
• Primary Completion: November 1, 2025
• Study Completion: November 1, 2025
• Last Updated: February 3, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)