CLIMATE: Assessing the clinical utility of miR-371a-3p as a marker of residual disease in stage 1 testicular germ cell tumour (TGCT) following orchiectomy: ANZUP 1906.

• DOI: 10.1200/jco.2023.41.16_suppl.tps5100
• Publication Date: 2023-06-04T11:49:12Z
• Authors: Ciara Conduit; Peter S. Grimison; Jeremy Howard Lewin; Aaron Richard Hansen; James F. Lynam; Andrew James Weic...; Phillip Parente; David Colin Campbell; Wei Hong; Gavin M. Marx; Orlaith Mary Heron; Anna Kuchel; Margaret Mary McJ...; Thomas Cusick; Antoinette Fontela; Sophie O Haire; Kristina Zlatic; Ian D. Davis; Ben Tran
• Keywords: Orchiectomy; Concordance; Clinical endpoint; Watchful waiting

TPS5100 Background: There is impetus to identify biomarkers in TGCT help select those at high-risk of relapse following orchiectomy and target interventions prevent over-treatment. miR-371 has been shown reliably predict presence active malignancy with higher accuracy than currently available biomarkers. More clinical evidence required ascertain its utility as a marker microscopic disease guide treatment recommendations stage 1 other settings. Methods: CLIMATE ANZUP1906 (ACTRN12622000247774) prospective, single-arm, non-interventional cohort study recruiting adults entering surveillance. Eligible participants are recruited within six weeks willing undergo surveillance accordance the Australian New Zealand Urogenital Prostate (ANZUP) Cancer Trials Group Surveillance Recommendations (or similar), without adjuvant treatment. Participants metastases, non-testicular primaries, or history contralateral ineligible. Serum, plasma, buffy coat samples collected consent every three months until 24 (and relapse, if applicable). will be assessed using established protocols. Clinical data, including treatment(s), surveillance, relapses captured Australia’s national registry, iTestis. Archival tissue from diagnosis ± identified for future translational research. The primary endpoint 12-month relapse-free survival positive/negative groups. Key secondary endpoints include during concordance between serum/plasma archival tissue, health economic analyses. Prior studies suggest ~20% post-orchidectomy positive. A sample size 200 result 20 relapses, 160 non-relapses individuals lost follow-up, permit description endpoint. Patient-level data contribute joint analysis parallel trials evaluating this setting, COG AGCT1531 SWOG1823. first participant was February 2022. 9/12 sites Australia have activated 47/200 (24%) enrolled. Recruitment expected take 36 months, followed by further follow-up. trial information: ACTRN12622000247774 .