Establishing a ctDNA Biomarker to Improve Organ Preserving Strategies in Patients With Rectal Cancer
Recruiting now
Conditions studied: Rectal Adenocarcinoma, Stage II Rectal Cancer AJCC v8, Stage IIA Rectal Cancer AJCC v8, Stage IIB Rectal Cancer AJCC v8, Stage IIC Rectal Cancer AJCC v8, Stage III Rectal Cancer AJCC v8, Stage IIIA Rectal Cancer AJCC v8, Stage IIIB Rectal Cancer AJCC v8, Stage IIIC Rectal Cancer AJCC v8
In brief
This study measures the levels of circulating tumor DNA (ctDNA) in patients with stage II-III rectal cancer before, during, and after treatment to find out if the presence or absence of ctDNA in patient's blood using the Signatera test can be used to gauge how different treatments may affect rectal cancer. ctDNA is DNA from the rectal cancer that is circulating in the blood. The purpose of this study is to understand if the way rectal tumors respond to standard treatment can be associated with varying levels of ctDNA.
Key facts
- Study ID
- NCT05081024
- Run by
- OHSU Knight Cancer Institute
- People needed
- 50
- Starts
- 2021-09-03
- Expected to finish
- 2026-09-03
- Last updated by the study team
- 2025-09-25
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Participant must provide written informed consent before any study-specific procedures or interventions are performed
- Participants aged >= 18 years
- Pathologically-confirmed stage II or III primary adenocarcinoma of the rectum:
- T3N0M0 - T4bN2M0
You may not qualify if…
- 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
Where it is running
- OHSU Knight Cancer Institute — Portland, Oregon, United States (enrolling)
- Fred Hutch — Seattle, Washington, United States (enrolling)
Full record on ClinicalTrials.gov
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