MASLD development in breast and colorectal cancer survivors
The Development of MASLD Among Survivors of Breast or Colorectal Cancer
This project will see how common MASLD and liver fibrosis are in adults who survived breast or colorectal cancer 5–10 years after diagnosis.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 200 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Bern Academic / other |
| Locations | 1 site (Bern) |
| Trial ID | NCT07280143 on ClinicalTrials.gov |
What this trial studies
This is an observational cohort conducted at the University of Bern enrolling adults who were diagnosed with breast or colorectal cancer 5–10 years earlier and have had no recurrence. Participants will undergo non-invasive liver screening including imaging (with an MRI sub-study for eligible patients) and clinical/metabolic data collection to measure liver fat and stiffness. People with known chronic liver disease or pregnancy are excluded, and MRI-ineligible participants can be excluded from the MRI sub-study. The study aims to estimate the prevalence and severity of MASLD and identify metabolic or treatment-related factors linked to fibrosis in this survivor population.
Who should consider this trial
Good fit: Adults aged 18 or older who were diagnosed with breast or colorectal cancer 5–10 years ago, have not had a recurrence or new cancer (with only specified minor exceptions), and can give informed consent are ideal candidates.
Not a fit: People with known or suspected chronic liver disease, pregnant individuals, or those who cannot undergo MRI (for the MRI sub-study) are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, the project could lead to earlier detection of liver disease in cancer survivors and inform targeted follow-up or prevention strategies.
How similar studies have performed: Non-invasive imaging and fibrosis screening have been useful in other high-risk groups, but applying these approaches specifically to breast and colorectal cancer survivors is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion criteria: * Signed Informed consent form * Age ≥ 18 years * Diagnosis of BC or CRC at least 5 years but no more than 10 years before enrollment, and no recurrence or new cancer diagnoses during this time period (except for superficial non-melanoma skin cancer or superficial bladder cancer or cancer in-situ). Patients who received/are still receiving adjuvant therapy may be included. Time period is calculated from date of first histological diagnosis of cancer. Exclusion criteria: * Known or suspected chronic hepatic disease * Pregnancy, or suspected pregnancy (as liver stiffness and fat content are often elevated but reverse after childbirth) * For the MRI sub-study: Contraindication to MRI, including: claustrophobia and presence of metal implants or devices or foreign metal objects in/on the body, such as pacemakers, defibrillators, prosthetic cardiac valves, cochlear implants, metal clips e.g., vascular clips, spinal cord stimulators or deep brain stimulators, shrapnel or bullet fragments, metal in the eyes, orthopedic hardware and piercings that cannot be easily removed.
Where this trial is running
Bern
- Department of Clinical Research, University of Bern — Bern, Switzerland (Recruiting)
Study contacts
- Principal investigator: Eva Segelov, Prof. — Department of Clinical Research, University of Bern
- Study coordinator: Study coordinator
- Email: evaluate.dcr@unibe.ch
- Phone: +41 79 804 04 05
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.