Status:
NOT_YET_RECRUITING
ctDNA-Informed Management of Early-Stage Rectal Cancer
Lead Sponsor:
University of California, Davis
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Rectal Adenocarcinoma
Rectal Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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 t...
Detailed Description
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 comple...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2028
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT07209215
Start Date
November 1 2025
End Date
May 1 2028
Last Update
October 6 2025
Active Locations (1)
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1
University of California Davis Comprehensive Cancer Center
Sacramento, California, United States, 95817