Supporting utility and representation in genomics-based clinical trial enrollment (SURGE): Interim findings.

Abstract

40 Background: Disparities in clinical trial enrollment are well documented, yet little attention is paid to genomic testing as a barrier. SURGE aims to increase rates of genomic testing, representation and access to genomics-based clinical trials. Here, we describe early findings. Methods: SURGE is a randomized feasibility phase II prospective clinical trial. Eligible participants include any adult age ≥18, diagnosed with advanced solid tumor malignancy or lymphoma, seeking care at Dana-Farber Cancer Institute since April 2023. Participants completed a 4-item validated survey attesting awareness and readiness of tumor somatic genomic testing and trials at consultation and were randomized to standard of care discussion with their assigned oncologist or video-based education +/- 1:1 genomic testing navigation. Genomic testing was completed by the Brigham and Women’s Hospital Center for Advanced Molecular Diagnostics, a CLIA-certified laboratory using OncoPanel (450 gene hybrid capture and next-generation sequencing panel) or Rapid Heme Panel (RHP; 88 gene hybrid-capture and amplicon-based next-generation sequencing panel). Results are reported by tier of pathogenicity and actionability with Tier 1 as most actionable, Tier 4 least actionable for OncoPanel; or pathogenic/likely pathogenic vs variant of uncertain significance (VUS) for RHP. Rates of genomic testing consent, completion, and navigation were collected with patient demographics and disease status. Results: From April 2023-July 2025, 40 adults (including 2 Black, 3 Latinx, 22 older adults 65+) consented (n=17 lung cancer, 6 colon, 2 cholangiocarcinoma, 2 pancreatic). Survey responses were as follows (respondents=36): 25 responded “yes” to awareness of and 27 to readiness for testing, 29 to awareness of and 27 to readiness for trials. 18 were randomized to standard of care, 5 to video-based education, and 18 to video + navigation. Of those consented, 25/30 patients had an OncoPanel test ordered by their provider (24 tumor-only, 1 paired tumor-germline; 2 had both OncoPanel + RHP ordered and resulted. Twenty-two OncoPanel samples resulted; 3 failed (2 - insufficient tumor, 1 - failed DNA extraction). Mean genomic testing turnaround time (TAT): 24 days (range 10-49); 6 (27%) Tier 1 as highest tier, 14 (64%) Tier 2, 2 (9%) Tier 3. Mean RHP TAT: 12.5 days (range 11-14); 1 highest Tier pathogenic, 1 highest Tier VUS. Two participants consented to clinical trial. Conclusions: Early SURGE findings indicate higher than previously reported rates of consent to genomic testing (83% vs. 40%) and actionable genomic alteration findings (88% vs. 73%). Enrollment is ongoing with pending analysis to correlate video-based education with or without navigation on genomic testing consent rates. Rigorous attention to genomic testing as an essential prerequisite to increase representation in genomics-based clinical trials is warranted. Clinical trial information: NCT05375643 .