ctDNA-Informed Management of Early-Stage Rectal Cancer
Part of paid clinical trials in Sacramento, California.
- Sponsor
- University of California, Davis
- Study ID
- NCT07209215
- Phase
- PHASE2
- Status
- Not Yet Recruiting
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Conditions
- Early-stage Rectal Cancer
- Locally Advanced Rectal Adenocarcinoma
- Rectal Adenocarcinoma
- Rectal Cancer
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Signatera Genome ultra-sensitive ctDNA blood test + total neoadjuvant therapy (TNT) — DRUGUse of Signatera Genome ultra-sensitive ctDNA blood test post-total neoadjuvant therapy (TNT) for ctDNA-informed treatment management of early-stage rectal cancer.
Study Details
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.
Key Dates
- Start date
- Mar 31, 2026
- Status verified
- Sep 2025
- Primary completion
- Nov 30, 2027
- Completion
- May 31, 2028
Study Design
- Enrollment
- 200 participants (estimated)
- Allocation
- NON_RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: ctDNA informed management arm (Watch and Wait surveillance)
- Experimental: Post TNT SOC surgery arm
Primary Outcome Measure
Pathologic complete response (pathCR) rate (ctDNA Informed Management Arm) [ Time Frame: Up to 2 years after TNT ]
Central Contacts
- Ankit Sarin, MD(916) 734-3772
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| University of California Davis Comprehensive Cancer Center | Sacramento | California | 95817 |
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