Protocol for Muscle Attenuation Cut-offs in Cirrhosis (NCT06593015) | Clinical Trial Compass
CompletedNot Applicable
Protocol for Muscle Attenuation Cut-offs in Cirrhosis
Italy1,296 participantsStarted 2019-01-01
Plain-language summary
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.
Who can participate
Age range
40 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
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
Exclusion Criteria:
Retrospective cohort:
* Multi-organ transplantation
* Re-transplantation
Prospective cohort:
* Patient on LT waiting lists
* Hepatocellular carcinoma (HCC)
* History of LT
* Concomitant neuromuscular disease
* Current malignancy other than non-melanocytic skin cancer
* History of serious extrahepatic disease
* HIV infection.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Definition of new L3/L3-L4 muscle attenuation cut-offs to define myosteatosis in relation to risk of death in patients with cirrhosis