Breast Cancer SurvivorsEVALUATENCT07280143
The Development of MASLD Among Survivors of Breast or Colorectal Cancer
An observational study of Breast Cancer Survivors and Colorectal (Colon or Rectal) Cancer Survivors, run by University of Bern at 1 site in Switzerland.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer Survivors, Colorectal (Colon or Rectal) Cancer Survivors, MASLD/MASH (Metabolic Dysfunction-Associated Steatotic Liver Disease / Metabolic Dysfunction-Associated Steatohepatitis)
- How many people
- 200 participants
- Where
- 1 siteSwitzerland
- Study dates
- 14 Nov 2025to 30 Nov 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Breast and colorectal cancer survivors
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland1 site, 1 recruiting
- Recruiting
Department of Clinical Research, University of Bern
Bern, 3010
Study team, +41 79 804 04 05, evaluate.dcr@unibe.ch
About this study
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.
Read more
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.
- Conditions
- Breast Cancer Survivors, Colorectal (Colon or Rectal) Cancer Survivors, MASLD/MASH (Metabolic Dysfunction-Associated Steatotic Liver Disease / Metabolic Dysfunction-Associated Steatohepatitis)
- Keywords
- MASLD, Cancer survivorship, Survivorship care, Non-invasive imaging, Liver fibrosis screening
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Breast cancer survivors | Not described | |
| Colorectal cancer survivors | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
High probability of fMASLD
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
Measured: Month 3
Secondary outcomes (16)
Participant age
Age of the participant at the time of enrollment, recorded in years.
Unit of Measure:
Years
Measured: Day 1 (at enrollment)
Participant sex
Sex of the participant recorded at the time of enrollment (male or female).
Unit of Measure:
Categorical (male/female)
Measured: Day 1 (at enrollment)
Body Mass Index (BMI)
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
Measured: Day 1 (at enrollment)
A Body Shape Index (ABSI)
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
Measured: Day 1 (at enrollment)
Waist Circumference
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)
Measured: Day 1 (at enrollment)
Cancer histology
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
Measured: Day 1 (at enrollment)
Cancer stage
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)
Measured: Day 1 (at enrollment)
Cancer treatment Received
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)
Measured: Day 1 (at enrollment)
Number of Treatment Cycles
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)
Measured: Day 1 (at enrollment)
Intervals Between Treatment Cycles
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
Measured: Day 1 (at enrollment)
Liver Stiffness Measurement (LSM)
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)
Measured: Month 3
Controlled Attenuation Parameter (CAP)
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)
Measured: Month 3
MRI-Based Liver Stiffness Measurement (MRI-LSM)
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)
Measured: Month 3
Proton Density Fat Fraction (PDFF)
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 (%)
Measured: Month 3
Agile 3+ Score
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)
Measured: Month 3
Agile 4 Score
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)
Measured: Month 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2025
- Study start14 Nov 2025
- Primary completion14 Jul 2027 (estimated)
- Study completion30 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast Cancer SurvivorsStudies of the same condition, open and under way.
- More trials run by University of BernThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Bern
- Sponsor type
- University, hospital or other
- Collaborators
- Insel Gruppe AG, University Hospital Bern
- Responsible party
- Sponsor
- Investigators
- Eva Segelov, Prof., Principal investigator, Department of Clinical Research, University of Bern
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07280143
- Sponsor's protocol ID
- EVALUATE
- Other IDs
- DRKS00038398
- Acronym
- EVALUATE
- Status last verified
- Dec 2025
- First submitted
- 1 Dec 2025
- Last updated
- 12 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Verschoor D, Hafele L, Oramalu OE, Berzigotti A, Aebersold DM, Bastiaansen J, Catucci D, Huber AT, Ineichen BV, Kohler A, Berger MD, Segelov E. Development of MASLD among survivors of breast or colorectal cancer (EVALUATE): protocol for a single-centre observational cross-sectional study. BMJ Open. 2026 Sep 25;16(9):e119603. doi: 10.1136/bmjopen-2026-119603.
PubMed 42790904
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Development of MASLD Among Survivors of Breast or Colorectal Cancer
- ClinicalTrials.gov ID
- NCT07280143
- Acronym / sponsor ID
- EVALUATE / EVALUATE
- Conditions
- Breast Cancer Survivors, Colorectal (Colon or Rectal) Cancer Survivors, MASLD/MASH (Metabolic Dysfunction-Associated Steatotic Liver Disease / Metabolic Dysfunction-Associated Steatohepatitis)
- Keywords
- MASLD, Cancer survivorship, Survivorship care, Non-invasive imaging, Liver fibrosis screening
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University of BernUniversity, hospital or other
- Collaborators
- Insel Gruppe AG, University Hospital Bern
- Study start
- 14 Nov 2025 (actual)
- Primary completion
- 14 Jul 2027 (estimated)
- Study completion
- 30 Nov 2027 (estimated)
- First posted
- 12 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Breast cancer survivors | – | – |
| Colorectal cancer survivors | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Breast and colorectal cancer survivors
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
16 secondary outcomes
Participant age
Time frame: Day 1 (at enrollment)
Participant sex
Time frame: Day 1 (at enrollment)
Body Mass Index (BMI)
Time frame: Day 1 (at enrollment)
A Body Shape Index (ABSI)
Time frame: Day 1 (at enrollment)
Waist Circumference
Time frame: Day 1 (at enrollment)
Cancer histology
Time frame: Day 1 (at enrollment)
Cancer stage
Time frame: Day 1 (at enrollment)
Cancer treatment Received
Time frame: Day 1 (at enrollment)
Number of Treatment Cycles
Time frame: Day 1 (at enrollment)
Intervals Between Treatment Cycles
Time frame: Day 1 (at enrollment)
Liver Stiffness Measurement (LSM)
Time frame: Month 3
Controlled Attenuation Parameter (CAP)
Time frame: Month 3
MRI-Based Liver Stiffness Measurement (MRI-LSM)
Time frame: Month 3
Proton Density Fat Fraction (PDFF)
Time frame: Month 3
Agile 3+ Score
Time frame: Month 3
Agile 4 Score
Time frame: Month 3
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2025.
- Derived from this study: PubMed 42790904Verschoor D, Hafele L, Oramalu OE, Berzigotti A, Aebersold DM, Bastiaansen J, Catucci D, Huber AT, Ineichen BV, Kohler A, Berger MD, Segelov E. Development of MASLD among survivors of breast or colorectal cancer (EVALUATE): protocol for a single-centre observational cross-sectional study. BMJ Open. 2026 Sep 25;16(9):e119603. doi: 10.1136/bmjopen-2026-119603.
- Study websiteLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Eva Segelov, Prof. principal investigator
Department of Clinical Research, University of Bern
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer Survivors and Colorectal (Colon or Rectal) Cancer Survivors, run by University of Bern at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Study coordinator (+41 79 804 04 05, evaluate.dcr@unibe.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
High probability of fMASLD (time frame: Month 3). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07280143, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Dec 2025.