Health Trials

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

ConditionsRectal AdenocarcinomaStage II Rectal Cancer AJCC v8Stage IIA Rectal Cancer AJCC v8Stage IIB Rectal Cancer AJCC v8Stage IIC Rectal Cancer AJCC v8Stage III Rectal Cancer AJCC v8Stage IIIA Rectal Cancer AJCC v8Stage IIIB Rectal Cancer AJCC v8Stage IIIC Rectal Cancer AJCC v8
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorOHSU Knight Cancer Institute

About this trial

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 criteria

Qualifiers

Participant must provide written informed consent before any study-specific procedures or interventions are performed

Participants aged >= 18 years

T3N0M0 - T4bN2M0

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Biopsy
  • Biospecimen Collection
  • Electronic Health Record Review

Treatment groups

50 Participants
are divided into 1 treatment group

Locations

2
OHSU Knight Cancer Institute97239, PortlandOregon, United States
Fred Hutch98109, SeattleWashington, United States

Sponsors and collaborators

OHSU Knight Cancer Institute

Lead sponsor

Natera, Inc.

Collaborator

Source ClinicalTrials.gov