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NCT Number: NCT07280143

The Development of MASLD Among Survivors of Breast or Colorectal Cancer

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.

Recruiting

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Clinical Research, University of Bern

Bern, 3010, Switzerland

Location status: Recruiting

Location contact

Study team

CONTACT

[email protected]

+41 79 804 04 05

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. High probability of fMASLD

    Time frame: 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

Secondary outcomes

  1. Participant age

    Time frame: Day 1 (at enrollment)

    Age of the participant at the time of enrollment, recorded in years.

    Unit of Measure:

    Years

  2. Participant sex

    Time frame: Day 1 (at enrollment)

    Sex of the participant recorded at the time of enrollment (male or female).

    Unit of Measure:

    Categorical (male/female)

  3. Body Mass Index (BMI)

    Time frame: Day 1 (at enrollment)

    Body mass index (BMI) of the participant at the time of enrollment, calculated as weight in kilograms divided by height in meters squared (kg/m²).

    Unit of Measure:

    kg/m²

  4. A Body Shape Index (ABSI)

    Time frame: Day 1 (at enrollment)

    A Body Shape Index (ABSI) of the participant at the time of enrollment, calculated using waist circumference, weight, and height to provide a normalized measure of body shape independent of BMI.

    Unit of Measure:

    Unitless

  5. Waist Circumference

    Time frame: Day 1 (at enrollment)

    Waist circumference of the participant at the time of enrollment, measured in centimeters at the midpoint between the lowest rib and the iliac crest.

    Unit of Measure:

    Centimeters (cm)

  6. Cancer histology

    Time frame: Day 1 (at enrollment)

    Histological classification of the participant's cancer type, determined from biopsy or surgical specimen according to standard pathological criteria.

    Unit of Measure:

    Categorical for breast cancer: for breast cancer:

    • Ductal carcinoma in situ (DCIS)
    • Invasive breast cancer (IDC/ILC)
    • Tripple negative breast cancer (TNBC)
    • Inflammatory breast cancer
    • Other

    Categorical for colorectal cancer:

    Adenocarinoma other

  7. Cancer stage

    Time frame: Day 1 (at enrollment)

    Stage of the participant's cancer at enrollment, determined using standard clinical or pathological staging criteria (e.g., TNM classification or other recognized staging system).

    Unit of Measure:

    Categorical (e.g., Stage I, II, III, IV)

  8. Cancer treatment Received

    Time frame: Day 1 (at enrollment)

    Type of treatment the participant is receiving at enrollment or during the study, categorized by modality (e.g., surgery, chemotherapy, radiation, immunotherapy, or combination therapy).

    Unit of Measure:

    Categorical (e.g., Chemotherapy, Targeted therapy, Hormone therapy, Immunotherapy, Radiation, Supportive or adjunct therapy)

  9. Number of Treatment Cycles

    Time frame: Day 1 (at enrollment)

    Number of treatment cycles received by the participant, recorded as the total count of completed cycles of the assigned therapy at the time of assessment.

    Unit of Measure:

    Count (number of cycles)

  10. Intervals Between Treatment Cycles

    Time frame: Day 1 (at enrollment)

    Time intervals between consecutive treatment cycles for the participant, measured in days from the end of one cycle to the start of the next.

    Unit of Measure:

    Days

  11. Liver Stiffness Measurement (LSM)

    Time frame: Month 3

    Liver stiffness measurement (LSM) of the participant, obtained using elastography or other validated imaging techniques, reported in kilopascals (kPa). LSM provides a quantitative assessment of liver fibrosis and can be used to monitor disease progression or response to treatment.

    Unit of Measure:

    Kilopascals (kPa)

  12. Controlled Attenuation Parameter (CAP)

    Time frame: Month 3

    Controlled Attenuation Parameter (CAP) measured via elastography, reported in decibels per meter (dB/m). CAP provides a quantitative assessment of liver steatosis and can be used to monitor disease severity or response to treatment.

    Unit of Measure:

    Decibels per meter (dB/m)

  13. MRI-Based Liver Stiffness Measurement (MRI-LSM)

    Time frame: Month 3

    Liver stiffness measured using magnetic resonance imaging (MRI-LSM), reported in kilopascals (kPa). MRI-LSM provides a non-invasive quantitative assessment of liver fibrosis and can be used to monitor disease progression or response to therapy.

    Unit of Measure:

    Kilopascals (kPa)

  14. Proton Density Fat Fraction (PDFF)

    Time frame: Month 3

    Proton Density Fat Fraction (PDFF) of the liver measured using MRI, reported as a percentage (%). PDFF provides a quantitative assessment of liver fat content and can be used to monitor liver steatosis and response to intervention.

    Unit of Measure:

    Percent (%)

  15. Agile 3+ Score

    Time frame: Month 3

    Agile 3+ is a composite, non-invasive score used to estimate the probability of advanced liver fibrosis (F3 or higher). It integrates clinical, laboratory, and imaging parameters to provide a continuous or categorical assessment of fibrosis severity, allowing monitoring of disease progression or response to therapy.

    Unit of Measure:

    Continuous score (unitless)

  16. Agile 4 Score

    Time frame: Month 3

    Agile 4 is a composite, non-invasive score used to estimate the probability of cirrhosis or very advanced liver fibrosis (F4). It combines clinical, laboratory, and imaging parameters to provide a continuous or categorical assessment, allowing monitoring of disease progression or response to therapy.

    Unit of Measure:

    Continuous score (unitless)

Study contacts

Contact information is provided by the study sponsor or research team.

Study coordinator

CONTACT

[email protected]

+41 79 804 04 05

Sponsors and collaborators

Lead sponsor

University of Bern

Other

Collaborators

  • Insel Gruppe AG, University Hospital Bern

Registry information

Acronym: EVALUATE

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Dec 12, 2025
Registry last updated
Dec 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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