Establishing a ctDNA Biomarker to Improve Organ Preserving Strategies in Patients With Rectal Cancer
OHSU Knight Cancer Institute
Summary
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.
Description
PRIMARY OBJECTIVE: I. To estimate the percentage of participants that achieve complete clinical response. SECONDARY OBJECTIVES: I. To assess circulating tumor deoxyribonucleic acid (ctDNA) status among participants receiving total neoadjuvant therapy (TNT). II. To assess molecular residual disease (MRD i.e., ctDNA status). III. To assess the rate of transabdominal surgery. IV. To assess the rate pathological complete response after surgery. V. To assess the rate of watch and -wait (W\&W) after TNT. VI. To assess disease-free survival (DFS). VII. To assess overall survival (OS). EXPLORATOR…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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
Interventions
- ProcedureBiopsy
Undergo biopsy
- ProcedureBiospecimen Collection
Undergo collection of blood and/or tissue samples
- OtherElectronic Health Record Review
Medical records are reviewed
Locations (2)
- OHSU Knight Cancer InstitutePortland, Oregon
- Fred HutchSeattle, Washington