NCT06593015Completed
Protocol for Muscle Attenuation Cut-offs in Cirrhosis
Study Protocol to Redefine Muscle Attenuation Cut-offs for Better Prediction of Mortality in Patients With Cirrhosis: a Comprehensive Post-hoc Validation Study
Source: ClinicalTrials.gov · Last updated 19 Sept 2024
Brief summary (registry, in English)
The goal of this observational study is to learn if new muscle attenuation cut-offs for the definition of myosteatosis can better predict survival in patients with cirrhosis. The main questions it aims to answer are: * Can these new muscle attenuation cut-offs more accurately diagnose myosteatosis (fat infiltration in muscle mass ) in cirrhosis? * Do these cut-offs work effectively across different patient groups, including men and women, those with obesity, and those with fluid retention in the abdomen? Researchers will compare patients with cirrhosis from a retrospective Canadian cohort to those from a prospective Italian cohort to see if the new cut-offs predict survival better than existing ones\*\*. Due to the retrospective nature of the study, no action is required from participants.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 1296 (actual)
- First submitted
- 4 Sept 2024
- Start date
- 1 Jan 2019
- Primary completion date
- 1 Dec 2021
- Lead sponsor
- University of Roma La Sapienza
- Diseases
- High blood pressure
- NCT number
- NCT06593015
What you commit to
- Study type: Observational
- Participants enrolled: 1296
- From 1 Jan 2019 to the primary completion date, 1 Dec 2021
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Multi-organ transplantation
- Re-transplantation
- Prospective cohort:
- Concomitant neuromuscular disease
Other illness
- History of LT
- Current malignancy other than non-melanocytic skin cancer
- History of serious extrahepatic disease
- HIV infection.
Other
- Retrospective cohort:
- Patient on LT waiting lists
- Hepatocellular carcinoma (HCC)
Who the study is looking for
- Retrospective cohort:
- Clinical, radiological and/or histological diagnosis of cirrhosis
- Abdominal CT-scan obtained as part of the LT evaluation
- Prospective cohort:
- Clinical, radiological and/or histological diagnosis of cirrhosis
- Age 40-75 years
- Abdominal CT-scan
Age in the registry: 40 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Department of Translational and Precision Medicine, Sapienza University of Rome Coordinator of this site? Confirm its status | Rome | Italy | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.