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) — DRUG
    Use 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

Locations (1)

FacilityCityStateZIPSite coordinators
University of California Davis Comprehensive Cancer CenterSacramentoCalifornia95817
Ankit Sarin, MD
916-734-3772

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