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

RECRUITINGSponsored by OHSU Knight Cancer Institute
Actively Recruiting
SponsorOHSU Knight Cancer Institute
Started2021-09-03
Est. completion2026-09-03
Eligibility
Age18 Years+
Healthy vol.Accepted
Locations2 sites
View on ClinicalTrials.gov →

NCT05081024

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

Age: 18 Years+Healthy volunteers accepted
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

Conditions10

CancerRectal 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

Locations2 sites

Oregon

1 site
OHSU Knight Cancer Institute
Portland, Oregon, 97239
Adel Kardosh, M.D.,Ph.D.503-494-5207kardosh@ohsu.edu

Washington

1 site
Fred Hutch
Seattle, Washington, 98109
Stacey Cohen, MD206-606-6658shiovitz@uw.edu

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