Lessons learned from clinical trial queries on small biopsy collections from an academic cancer center

e14016 Background: Small biopsies and cytology specimens are becoming increasingly important for clinical trials and biomarker testing. Thus, institutions must ensure that there is adequate lesional material meeting specifications for a multitude of different protocols, which can involve rapid on-site evaluation (ROSE). The aim of this study is to look at the recent clinical trial biopsy characteristics and feedback on these collections at our institution. Methods: Clinical trial biopsies performed at our institution and trial feedback (so called “queries”) were analyzed from the past two years (2017-2019). The query data was reviewed in detail, in addition to protocol modifications related to biopsy requirements and study protocol changes. Results: A total of 698 biopsy collections were performed for clinical trial purposes for 95 trials, with the majority of these requiring biopsies at more than 1 time point (63.2%), for phase 1 or 2 trials (92.6%), and for specific tumor types (67.4%). Only 18 (18.9%) of the 95 trials requiring fresh tissue biopsies provided feedback. This included 90 (12.9%) cases, of which 27 (30.0%) had queries regarding insufficient (10, 37.0%) or borderline (17, 63.0%) tumor, and only 1 (3.7%) of these had ROSE by cytology. ROSE was performed due to institutional guidelines (45.3%), requirement by study (1.1%), or trial modification (5.3%).(Table). Conclusions: This investigation shows the high volume of clinical trial biopsies managed at our academic cancer center. Feedback from trials is low at 18.9%, and frequently involves suboptimal cases without ROSE at acquisition, which has led to more widespread adoption of ROSE to mitigate insufficient biopsies and repeat procedures. The high volume of clinical trial biopsies and variability in trial needs necessitates a collaborative multi-disciplinary network to facilitate these important biopsies for cancer patients. [Table: see text]