ctDNA-Informed Management of Early-Stage Rectal Cancer

This is a phase 2 pragmatic study to examine the utility of ctDNA-informed treatment management for participants with early-stage rectal cancer using the Signatera Genome assay. The primary aims are to 1) assess pathologic complete response (path CR) in the ctDNA informed management arm; 2) assess pathologic complete response (path CR) in the post total neoadjuvant therapy (TNT) standard of care (SOC) surgery arm; and 3) assess disease free survival (DFS) in the ctDNA informed management arm.

NCT Number	NCT07209215
Lead Sponsor	University of California, Davis Collaborators: National Cancer Institute (NCI)
Conditions	Rectal Adenocarcinoma, Rectal Cancer, Early-stage Rectal Cancer, Locally Advanced Rectal Adenocarcinoma
Enrollment	200 participants
Start Date	2026-10
Primary Completion	2028-05 (estimated)
Study Completion	2028-12 (estimated)
Updated on ClinicalTrials.gov	2026-08-05