What this study is
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's being tested
- Biopsy
Intervention · PROCEDURE
Undergo biopsy
- Biospecimen Collection
Intervention · PROCEDURE
Undergo collection of blood and/or tissue samples
- Electronic Health Record Review
Intervention · OTHER
Medical records are reviewed
Study details
- Sponsor
- OHSU Knight Cancer Institute
- Conditions
- Rectal Adenocarcinoma · Stage II Rectal Cancer AJCC v8 · Stage IIA Rectal Cancer AJCC v8 · Stage IIB Rectal Cancer AJCC v8 · Stage IIC Rectal Cancer AJCC v8 · Stage III Rectal Cancer AJCC v8 · Stage IIIA Rectal Cancer AJCC v8 · Stage IIIB Rectal Cancer AJCC v8 · Stage IIIC Rectal Cancer AJCC v8
- Enrolling
- 50 people
- Starts
- 2021-09-03
- Est. completion
- 2027-09-03
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years and overSex ALLHealthy volunteers Not acceptedYou may qualify if
- 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
You can't join if
- 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
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (2)
2 openOHSU Knight Cancer Institute
Portland, Oregon, United States
- Adel Kardosh, M.D.,Ph.D. · Contact503-494-5207kardosh@ohsu.edu
- Adel Kardosh, M.D.,Ph.D. · Principal investigator
Recruiting- Recruiting
Study team
Sponsor
OHSU Knight Cancer Institute
Study ID STUDY00022247
Principal investigator
Adel Kardosh, M.D.,Ph.D.
OHSU Knight Cancer Institute
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.