The Development of MASLD Among Survivors of Breast or Colorectal Cancer (EVALUATE)

University of Bern

Status: Enrolling

Conditions: Breast Cancer Survivors; Colorectal (Colon or Rectal) Cancer Survivors; MASLD/MASH (Metabolic Dysfunction-Associated Steatotic Liver Disease / Metabolic Dysfunction-Associated Steatohepatitis)

Study type: Observational

Funder types: Other

Identifiers

NCT07280143

EVALUATE

DRKS00038398 (Registry Identifier)

Details and patient eligibility

About

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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

200 participants in 2 patient groups

Breast cancer survivors

Colorectal cancer survivors