Development of MASLD among survivors of breast or colorectal cancer (EVALUATE): protocol for a single-centre...

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.

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.

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.

NCT07280143/DRKS00038398.