Development of MASLD among survivors of breast or colorectal cancer (EVALUATE): protocol for a single-centre observational cross-sectional study
Daniëlle Verschoor, Lucian Häfele, Ogo E Oramalu, Annalisa Berzigotti, Daniel M Aebersold, Jessica Bastiaansen, Damiano Catucci, Adrian T Huber, Benjamin V Ineichen, Andreas Kohler, Martin D Berger, Eva SegelovBackground
Chronic inflammation links cancer aetiologically to other diseases; therefore many cancer survivors live with long-term effects and comorbidities. While it becomes common place to outline long-term care in survivorship plans, liver health is often overlooked, with potential underdiagnosis of metabolic-dysfunction-associated steatotic liver disease (MASLD). Detecting early signs of MASLD is crucial, with new therapeutics able to prevent and even reverse liver damage. There is a need to understand its prevalence in cancer survivors, which is now possible with non-invasive tools such as vibration-controlled transient elastography (VCTE), which makes screening viable. Therefore, our study aims to address whether cancer survivors constitute a high-risk population for MASLD.
Methods and analysis
The EVALUATE Study is an observational, single-centre, cross-sectional study co-designed with patient and public involvement. It aims to assess the prevalence of fibrotic MASLD (fMASLD) and precursor conditions (non-fibrotic MASLD and steatotic liver disease) among 200 participants who were diagnosed with breast cancer or colorectal cancer 5–10 years ago, without recurrence. Participants’ risk of fMASLD will be determined using VCTE and blood-based biomarkers. A subset with indeterminate risk will also undergo MRI of the liver. Data will be analysed using logistic regression (univariable and multivariable) to examine patient-related, tumour-related and treatment-related risk factors for fMASLD.
Ethics and dissemination
This study involves human participants and was approved by the Cantonal Ethics Committee of Bern (2025-00890). Participants gave informed consent to participate in the study before taking part. The results will be communicated through peer-reviewed publications and academic conferences.
Trial registration number