The trial will use Natera's Signatera test to determine patient enrollment eligibility based on the presence of ctDNA and to evaluate response based on ctDNA clearance.
Results from the Phase II INSPIRE study showed that change in ctDNA from baseline, as gauged by customized assays, predicted response to pembrolizumab.
Investigators reported on how ctDNA, measured using Natera's patient-specific Signatera assays, corresponded to a patient's disease progression and other biomarkers.
Natera's Signatera test will be used to select and monitor eligible patients with KRAS-mutant tumors who have molecular residual disease after surgery.
The multi-center registry study aims to measure the clinical impact of serial testing with Signatera in patients with stage II or stage III colorectal cancer.
Two new studies of stage I to III CRC suggest that the presence of ctDNA in the months after surgery or chemotherapy can help identify patients who go on to relapse.
The company believes that blood-based exome sequencing can increase the applicability of its Signatera assays and could serve as a reflex to interrogate detected recurrences.
Clinical researchers at AACR discussed a wide range of approaches focusing on several different potential use-cases in the detection or assessment of early cancers.
