The CLIMATE study is a cohort study, a prospective cohort study, designed to examine the clinical utility of miR-371 in patients with stage I testicular cancer. Testicular cancer is a highly curable cancer, as I’m sure you’re aware, but following orchiectomy for stage I disease some patients still do recur. At the moment there’s a subset of patients deemed to be at clinical high risk of recurrence that may receive adjuvant chemotherapy, but the use of adjuvant chemotherapy in that setting results in the overtreatment of the vast majority of patients which may lead to long-term toxicities that aren’t necessary.

So we need new promising biomarkers to truly identify the patients at highest risk of recurrence. miR-371 is one of these biomarkers. So it’s highly expressed in testicular cancer and it’s also detectable in blood. There have been conflicting results about its utility as a marker of minimal residual disease – some studies using a quantitative assay have demonstrated promising results, other studies using a qualitative assay have demonstrated disappointing results. So understanding the discordance between results from these retrospective studies, we went ahead and conducted the CLIMATE study, which is an Australian and New Zealand study through the ANZUP group, enrolling 200 patients across 12 sites with stage I testicular cancer. We’re collecting microRNA, we’re collecting serum and plasma to assess for miR-371 at baseline post-orchiectomy and then three monthly out to two years and at recurrence.

What we will report is that at baseline, miR-371, if it’s positive it is strongly predictive for development of recurrence. If it’s negative it means the likelihood of recurrence is very low. miR-371 at baseline outperforms all clinical biomarkers for both stage I testicular seminoma and stage I testicular non-seminoma. So this is the most promising biomarker out there yet to identify patients at risk of recurrence.

We hope that the next steps for it would be to design clinical trials to assess the utility of adjuvant chemotherapy being based upon a miR-371 result.