Establishing a ctDNA Biomarker to Improve Organ Preserving Strategies in Patients With Rectal Cancer
Recruiting · NCT05081024 · Observational (researchers observe without assigning treatment) · Lead sponsor: OHSU Knight Cancer Institute
View the official record on ClinicalTrials.gov →Interventions studied
BiopsyBiospecimen CollectionElectronic Health Record Review
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
Inclusion criteria
- 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
Exclusion criteria
- 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
2 locations listed across 2 US states.
- OHSU Knight Cancer Institute - Portland, Oregon, United States
- Fred Hutch - Seattle, Washington, United States