Actively Recruiting
The Development of MASLD Among Survivors of Breast or Colorectal Cancer
Led by University of Bern · Updated on 2025-12-12
200
Participants Needed
1
Research Sites
19 weeks
Total Duration
On this page
Sponsors
U
University of Bern
Lead Sponsor
I
Insel Gruppe AG, University Hospital Bern
Collaborating Sponsor
AI-Summary
What this Trial Is About
Metabolic-associated steatotic liver disease (MASLD), also known as non-alcoholic fatty liver disease, happens when fat builds up in the liver due to problems with metabolism, such as obesity, diabetes, or high blood pressure. MASLD can range from mild to severe, with advanced cases causing liver inflammation, scarring, and potentially liver failure. Cancer survivors are at higher risk because of changes in metabolism, lifestyle, and cancer treatments, yet MASLD is often underdiagnosed in this group. This observational study by the University of Bern uses non-invasive methods like vibration-controlled transient elastography (VCTE or FibroScan®) and Magnetic Resonance Imaging (MRI) to check for signs of fibrotic MASLD in breast or colorectal cancer survivors. Participants may also have blood tests to calculate scores indicating the risk of advanced MASLD. If the main results are unclear, participants might join an MRI sub-study for further evaluation. Participants will be assessed at enrollment and three months later with measures including liver stiffness, fat content, body measurements, cancer history, and treatment details. The study aims to improve early detection and monitoring of MASLD in cancer survivors using safer, less painful tests than liver biopsy. The findings could help develop better guidelines and care for those at risk of liver problems after cancer.
CONDITIONS
Brief Title
The Development of MASLD Among Survivors of Breast or Colorectal Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent form
- Age 18 years or older
- Diagnosis of breast or colorectal cancer at least 5 years but no more than 10 years before enrollment
- No recurrence or new cancer diagnoses during this time, except for superficial non-melanoma skin cancer, superficial bladder cancer, or cancer in-situ
- Patients who have received or are still receiving adjuvant therapy may be included
You will not qualify if you...
- Known or suspected chronic liver disease
- Pregnancy or suspected pregnancy
- For MRI sub-study: contraindications to MRI such as claustrophobia or metal implants/devices in or on the body that cannot be removed (e.g., pacemakers, defibrillators, cochlear implants, metal clips, spinal cord stimulators, shrapnel, orthopedic hardware, or piercings)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - At Month 3 after enrollment
Participants undergo assessments including Liver Stiffness Measurement, Controlled Attenuation Parameter, MRI-Based Liver Stiffness Measurement, Proton Density Fat Fraction, Agile 3+ and Agile 4 Scores to evaluate liver health.
1 visit (in-person)
Duration - Up to 4 years after initial assessments
Participants are observed over time to monitor the development of MASLD among breast or colorectal cancer survivors.
Trial Site Locations
Total: 1 location
1
Department of Clinical Research, University of Bern
Bern, Switzerland, 3010
Actively Recruiting
Research Team
S
Study coordinator
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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