NCT07209215

ctDNA-Informed Management of Early-Stage Rectal Cancer

ULtra sensiTive ctDNA-Informed Management eArly-stage recTal cancEr (ULTIMATE)

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: University of California, Davis · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Two cohorts of participants will be enrolled: Cohort A (participants appropriate for receiving TNT) and Cohort B (TNT already performed at UC Davis Health or externally). At Time A after TNT is completed and based on ctDNA assay results, the clinical decision will be made to put participants into one of two arms: the ctDNA informed management arm (Watchful Waiting \[WW\] surveillance) or the post TNT SOC surgery arm; participants will be monitored for ctDNA positivity for up to 5 years.

Conditions

• Rectal Adenocarcinoma
• Rectal Cancer
• Early-stage Rectal Cancer
• Locally Advanced Rectal Adenocarcinoma

Interventions

Type	Name	Description
DRUG	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.

Timeline

• Start date: 2026-03-01
• Primary completion: 2027-11-01
• Completion: 2028-05-01
• First posted: 2025-10-06
• Last updated: 2026-01-20

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study