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ctDNA-Informed Management of Early-Stage Rectal Cancer
Sponsor: University of California, Davis
Summary
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.
Official title: ULtra sensiTive ctDNA-Informed Management eArly-stage recTal cancEr (ULTIMATE)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
200
Start Date
2026-03
Completion Date
2028-05
Last Updated
2026-01-20
Healthy Volunteers
No
Conditions
Interventions
Signatera Genome ultra-sensitive ctDNA blood test + total neoadjuvant therapy (TNT)
Use of Signatera Genome ultra-sensitive ctDNA blood test post-total neoadjuvant therapy (TNT) for ctDNA-informed treatment management of early-stage rectal cancer.
Locations (1)
University of California Davis Comprehensive Cancer Center
Sacramento, California, United States