跳至主要内容
临床试验/NCT07280143
NCT07280143招募中不适用

The Development of MASLD Among Survivors of Breast or Colorectal Cancer

University of Bern1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2025年11月14日最近更新:

试验速览

阶段
不适用
状态
招募中
入组人数
200
试验地点
1
主要终点
High probability of fMASLD

研究概览

简要总结

A metabolic issue is a condition where the body has problems with converting food into energy, using energy or storing energy properly. Examples of metabolic issues include obesity, diabetes, or high blood pressure

MASLD -Metabolic-associated steatotic liver disease - also known as non-alcoholic fatty liver disease, is a condition where fat builds up in the liver due to metabolic issues. Excess liver fat can cause inflammation, scaring, also known as fibrosis, and over time, lead to liver failure.

MASLD can have different severities. Non-fibrotic MASLD is when there is a small amount of fat in the liver and usually does not cause major problems. However, it can get worse over time and can develop into fibrotic MASLD.

MASLD is very common, about one-third of the world's population is affected. In Switzerland, it is predicted that one-quarter of the Swiss population is affected by it. MASLD can affect anyone who has any metabolic issues, however it seems like some medications, such as cancer treatments, could play a role in MASLD development.

Studying MASLD is important because it is very common. Learning more about it can help doctors find better ways to diagnose and treat the condition.

Furthermore, it is important to find out who would be more likely to develop MASLD. People who are more likely could maybe do some regular testing to diagnose it early and start treatment before it is worsening. Early diagnosis is important since liver damage can be reversed with lifestyle changes, diet or medication.

Cancer survivors are at a higher risk of developing MASLD due to changes in their metabolism, lifestyle as well as side effects of cancer treatments. However, MASLD is often underdiagnosed in cancer survivors, even though it can increase the risk of future health complications.

Currently, liver biopsy is the standard method of diagnosing MASLD, as it provides the most accurate results. However, liver biopsy is uncomfortable and carries risks like pain and infections.

Newer non-invasive technologies, such as ultrasound-based vibration-controlled transient elastography (VCTE, also known as FibroScan®) and Magnetic Resonance Imaging (MRI), show promise in detecting liver fibrosis earlier and more safely. However, they are not yet widely used because they are not as precise as biopsy at detecting liver inflammation.

EVALUATE is an observational study performed by the Department of Clinical Research at the University of Bern. In collaboration with the Department of Hepatology, Inselspital, University Hospital of Bern and the Department of Radiology, University Cancer Centre Inselspital.

EVALUATE will use two of the newer, less painful methods - VCTE and MRI to check for signs of fibrotic MASLD. Combined with a blood test, a score can be calculated to see if someone is at high-risk for advanced MASLD.

In the case that the results from the main study are uncertain, the participant will be asked to participate in an MRI sub study.

This study will help improve ways to check for liver disease in cancer survivors, leading to early detection and quicker treatment. Eventually the information of this study could help create better guidelines and improve care for cancer survivors at risk of liver problems.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

High probability of fMASLD

时间窗: Month 3

Description: Dichotomous measure (Yes/No) of high probability of fibrotic MASLD (fMASLD) based on FAST and MAST score thresholds: * Yes if the FAST score indicates high probability (FAST ≥ 0.67), or * Yes if the FAST score indicates uncertain probability (FAST \> 0.35 and \< 0.67) and the MAST score indicates high probability (MAST ≥ 0.242). * No otherwise. Unit of Measure: Yes/No

次要结局

  • Cancer treatment Received(Day 1 (at enrollment))
  • Number of Treatment Cycles(Day 1 (at enrollment))
  • Body Mass Index (BMI)(Day 1 (at enrollment))
  • Proton Density Fat Fraction (PDFF)(Month 3)
  • A Body Shape Index (ABSI)(Day 1 (at enrollment))
  • Waist Circumference(Day 1 (at enrollment))
  • Cancer histology(Day 1 (at enrollment))
  • Cancer stage(Day 1 (at enrollment))
  • Participant age(Day 1 (at enrollment))
  • Participant sex(Day 1 (at enrollment))
  • Intervals Between Treatment Cycles(Day 1 (at enrollment))
  • Liver Stiffness Measurement (LSM)(Month 3)
  • Controlled Attenuation Parameter (CAP)(Month 3)
  • MRI-Based Liver Stiffness Measurement (MRI-LSM)(Month 3)
  • Agile 3+ Score(Month 3)
  • Agile 4 Score(Month 3)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验

The Development of MASLD Among Survivors of Breast... | 临床试验