RecruitingNCT05081024

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


Sponsor

OHSU Knight Cancer Institute

Enrollment

50 participants

Start Date

Sep 3, 2021

Study Type

OBSERVATIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Inclusion Criteria4

  • 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 Criteria3

  • 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 Institute

Portland, Oregon, United States

Fred Hutch

Seattle, Washington, United States

View Full Details on ClinicalTrials.gov

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NCT05081024


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