A Phase 2 interventional study of Signatera Genome ultra-sensitive ctDNA blood test + total neoadjuvant therapy (TNT) in Rectal Adenocarcinoma, Rectal Cancer and Early-stage Rectal Cancer, sponsored by University of California, Davis. Not yet recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-05.
Sponsored by University of California, Davis · Phase 2, Interventional, and Treatment
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.
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.
1,762 studies on the registry are indexed under Rectal Neoplasms; 518 are open to participants now.
This study's planned enrollment of 200 is above the median of 65 across 1,298 interventional studies indexed under Rectal Neoplasms.
Browse Rectal Neoplasms studies →University of California, Davis is the lead sponsor of 798 studies on the registry; 146 are open to participants now.
Of its 65 completed or terminated interventional studies of FDA-regulated products, 43 (66%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Drug: Signatera Genome ultra-sensitive ctDNA blood test + total neoadjuvant therapy (TNT)
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.
Pathologic complete response (pathCR) rate (ctDNA Informed Management Arm)
Percent of participants with local regrowth within 2 years of total neoadjuvant therapy (TNT)
Time frame: Up to 2 years after TNT
Pathologic complete response (pathCR) rate (Post TNT SOC Surgery Arm)
Percent of participants with local regrowth within 2 years of TNT
Time frame: Up to 2 years after TNT
Disease-free survival (DFS) rate (ctDNA Informed Management Arm)
Median interval from first date of TNT to the first occurrence of locoregional failure, distant recurrence, a new invasive colorectal primary cancer.
Time frame: Up to 2 years after TNT
Frequency of local regrowth (ctDNA Informed Management Arm)
Percentage of participants with local regrowth within 2 years of TNT
Time frame: Up to 2 years after TNT
This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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University of California, Davis