ctDNA-Informed Management of Early-Stage Rectal Cancer
Starting soon · Phase 2
Conditions studied: Rectal Adenocarcinoma, Rectal Cancer, Early-stage Rectal Cancer, Locally Advanced Rectal Adenocarcinoma
In brief
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 facts
- Study ID
- NCT07209215
- Run by
- University of California, Davis
- People needed
- 200
- Starts
- 2026-10-01
- Expected to finish
- 2028-12-01
- Last updated by the study team
- 2026-08-05
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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
Where it is running
- University of California Davis Comprehensive Cancer Center — Sacramento, California, United States
Full record on ClinicalTrials.gov
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