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Establishing a ctDNA Biomarker to Improve Organ Preserving Strategies in Patients With Rectal Cancer

RecruitingObservational study

Who can join

Ages 18 and older · All sexes

Full eligibility criteria
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

About the study

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.

What is being tested

Sponsor: OHSU Knight Cancer Institute · Participants: 50 · Started: Sep 3, 2021

Contact the study team

Official record on ClinicalTrials.gov — NCT05081024

Locations in the U.S.

OregonOHSU Knight Cancer Institute, Portland
WashingtonFred Hutch, Seattle

Conditions

From ClinicalTrials.gov, data retrieved Sep 29, 2026. Each study sets its own eligibility; the study team decides who can join.