Pre-Implementation Assessment of the Acceptability of Using Circulating microRNAs for Follow-Up of Malignant Germ-Cell Tumors

Background. MicroRNAs from the miR-371∼373 and miR-302/367 clusters, particularly miR-371a-3p, are promising biomarkers for blood-based diagnosis/disease-monitoring of malignant germ-cell-tumors (GCTs) and nearing clinical implementation. These biomarkers have superior sensitivity/specificity compared with current markers alpha-fetoprotein (AFP) and human-chorionic-gonadotropin (HCG). We explored patient acceptability of using circulating microRNAs to replace multiple serial CT-scans in malignant-GCT follow-up. Methods. Two workshops, involving an interactive presentation and focus-group. Discussions were digitally recorded and transcribed verbatim. Qualitative thematic analysis of transcripts identified key themes. Results. Prior to the workshops, potential participants expressed concern about adoption of new blood tests due to personal experiences of the limitations of existing (AFP/HCG) markers. Twelve males with malignant-GCT diagnosis aged 22-57y, currently 26-59y, participated; all in follow-up. Three had experienced recurrence. Participants had cumulative exposure to between 1-15 CT-scans. Data saturation was reached at the second workshop; five themes emerged underpinning preference for microRNA testing versus CT-scans: 1) increased sensitivity/safety; 2) reduced financial costs; 3) reduced time for test/results; 4) practicalities; and 5) reduced anxiety. However, some participants perceived an increased diagnostic capacity of CT-scans versus blood-testing. Conclusion. This first user consultation of circulating microRNA testing for future malignant-GCT follow-up suggests high acceptability with potential patient and healthcare system benefits. MicroAbstract MicroRNAs are short, non-protein-coding RNAs. Circulating microRNA testing is likely to transform future management for testicular cancer patients, including for diagnosis, disease-monitoring and follow-up. Here, we undertook patient and public involvement workshops to explore consumer views on replacing routine serial CT scans with non-invasive blood-based microRNA testing. Our user consultation study suggests high acceptability of this test with benefits versus traditional CT scan-based follow-up.