NCT07209215Not yet recruitingPhase 2
ctDNA-Informed Management of Early-Stage Rectal Cancer
ULtra sensiTive ctDNA-Informed Management eArly-stage recTal cancEr (ULTIMATE)
Source: ClinicalTrials.gov · Last updated 5 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 200 (estimated)
- First submitted
- 30 Sept 2025
- Start date
- Oct 2026
- Primary completion date
- May 2028
- Lead sponsor
- University of California, Davis
- Diseases
- Colorectal cancer
- NCT number
- NCT07209215
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 200
- From Oct 2026 to the primary completion date, May 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior treatment for rectal cancer, except for cohort B.
Other illness
- Evidence of distant metastatic disease on staging imaging (CT chest with abdominopelvic imaging by CT or MRI) within 8 weeks of enrollment.
- Any condition that in the opinion of the investigator would interfere with the participant's safety or compliance while on trial
Other
- Patients on hemodialysis.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of California Davis Comprehensive Cancer Center Coordinator of this site? Confirm its status | Sacramento | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.