anchor Kasi PM, Sawyer S, Guilford J, et al. "BESPOKE study protocol: a multicentre, prospective observational study to evaluate the impact of circulating tumour DNA guided therapy on patients with colorectal cancer." BMJ Open. 2021;11(9):e047831. The peer-reviewed design paper for BESPOKE CRC (ClinicalTrials.gov NCT04264702), a multicenter prospective observational study of stage II/III/IV colorectal cancer using a tumor-informed ctDNA assay to characterize the impact of ctDNA-guided decisions on adjuvant chemotherapy choice and downstream recurrence outcomes. Establishes the design that the sub-topic's spine names alongside CIRCULATE-Japan, DYNAMIC, and GALAXY: post-resection ctDNA assessment in the MRD window plus longitudinal surveillance, with adjuvant chemotherapy decisions left to clinicians and ctDNA dynamics treated as the prognostic/predictive readout. Notes on bearing: this is the protocol paper, not the trial readout; the interim analysis is currently in abstract form (JCO 2024;42(3 suppl):9, ASCO GI) and is expected to be superseded by a full primary publication, at which point a propose_supersedes is the natural follow-up. Like CIRCULATE-Japan/GALAXY, BESPOKE-CRC is observational rather than randomized, and its population is broader than resected stage II colon cancer (includes stage III and stage IV); its bearing on the sub-topic's stage II question is via the ctDNA-MRD biology and the observed clinician/patient adjuvant-decision behavior it documents, not a stage II-specific randomized comparison.

nod_0ee5b925-e844-4dd9-96cd-e18e80680db5

Source