Actively Recruiting
Establishing a ctDNA Biomarker to Improve Organ Preserving Strategies in Patients With Rectal Cancer
Led by OHSU Knight Cancer Institute · Updated on 2025-09-25
50
Participants Needed
2
Research Sites
N/A
Total Duration
On this page
Sponsors
O
OHSU Knight Cancer Institute
Lead Sponsor
N
Natera, Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying patients with stage II-III rectal adenocarcinoma to understand how circulating tumor DNA (ctDNA) levels in the blood relate to tumor response during and after treatment. The study aims to determine if the presence or absence of ctDNA measured by the Signatera test can indicate how rectal cancer responds to therapies, including total neoadjuvant therapy (TNT). This research is observational and focuses on improving organ-preserving strategies in rectal cancer care. Participants will have blood samples collected before starting any neoadjuvant therapy, every two months during TNT, and then every three months for up to three years after completing TNT. Medical records will be reviewed, and tissue samples may be collected if archival tissue is not available. The study tracks several outcomes such as complete clinical response, ctDNA status, surgery rates, pathological response, watch-and-wait strategy use, disease-free survival, and overall survival. During the study, participants will undergo regular blood collection and medical record reviews to monitor ctDNA levels and clinical outcomes. The primary outcome is the rate of complete clinical response within three months after TNT. Secondary outcomes include ctDNA positivity, surgery rates, and survival measures followed for up to three years. This long-term observation will help characterize ctDNA patterns and their potential prognostic value in rectal cancer treatment.
CONDITIONS
Brief Title
Establishing a ctDNA Biomarker to Improve Organ Preserving Strategies in Patients With Rectal Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participant must provide written informed consent before any study-specific procedures or interventions are performed
- Participants aged 60 18 years
- Pathologically-confirmed stage II or III primary adenocarcinoma of the rectum (T3N0M0 to T4bN2M0)
You will not qualify if you...
- Has radiologic evidence of distant metastases at the time of screening/enrollment
- Has received prior treatment for their rectal adenocarcinoma
- Requires or has received blood transfusion within 1 month of study enrollment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to 3 years
Participants undergo blood sample collections at baseline, every 2 months during total neoadjuvant therapy (TNT), and every 3 months for up to 3 years after TNT completion. Medical records are reviewed, and tissue samples may be collected if archival tissue is unavailable.
Blood sample collections at baseline, every 2 months during TNT, then every 3 months for up to 3 years
Trial Site Locations
Total: 2 locations
1
OHSU Knight Cancer Institute
Portland, Oregon, United States, 97239
Actively Recruiting
2
Fred Hutch
Seattle, Washington, United States, 98109
Actively Recruiting
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here