Clinical trial · Interventional
ctDNA-Informed Management of Early-Stage Rectal Cancer
ULtra sensiTive ctDNA-Informed Management eArly-stage recTal cancEr (ULTIMATE)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Early-stage Rectal Cancer | Rectal Neoplasm | PROBABILISTIC | 0.70 |
| Locally Advanced Rectal Adenocarcinoma | Rectal Adenocarcinoma | CURATED_BROADER | 0.78 |
| Rectal Adenocarcinoma | Rectal Adenocarcinoma | ONTOLOGY_EXACT | 0.98 |
| Rectal Cancer | Malignant Rectal Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Signatera Genome ultra-sensitive ctDNA blood test + total neoadjuvant therapy (TNT) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- ctDNA informed management arm (Watch and Wait surveillance)
- interventionNames
- Drug: Signatera Genome ultra-sensitive ctDNA blood test + total neoadjuvant therapy (TNT)
- type
- EXPERIMENTAL
- label
- Post TNT SOC surgery arm
- interventionNames
- Drug: Signatera Genome ultra-sensitive ctDNA blood test + total neoadjuvant therapy (TNT)
Primary outcomes (3)
- measure
- Pathologic complete response (pathCR) rate (ctDNA Informed Management Arm)
- timeFrame
- Up to 2 years after TNT
- description
- Percent of participants with local regrowth within 2 years of total neoadjuvant therapy (TNT)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Tumor tissue histologically confirming rectal adenocarcinoma that is available for Natera ctDNA assay. * Cohort A only: Patients appropriate for receiving TNT including chemotherapy and chemoradiation. * Cohort B only: TNT must have included at least 4 cycles of CAPEOX or 6 cycles of FOLFOX and at least 45 Gy in 25 fractions to the pelvis during chemoradiation. * Patients ≥18 years of age at time of consent. * Ability to understand and willingness to sign the informed consent form (ICF). * Ability and stated willingness to adhere to the study visit schedule and protocol procedures/requirements. Exclusion Criteria: * Prior treatment for rectal cancer, except for cohort B. * Evidence of distant metastatic disease on staging imaging (CT chest with abdominopelvic imaging by CT or MRI) within 8 weeks of enrollment. * Patients on hemodialysis. * Any condition that in the opinion of the investigator would interfere with the participant's safety or compliance while on trial
References
Publications (0)
Data not yet available