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

Rectal Adenocarcinoma Stage II Rectal Cancer AJCC v8 Stage III Rectal Cancer AJCC v8 Stage IIA Rectal Cancer AJCC v8 Stage IIB Rectal Cancer AJCC v8 Stage IIC Rectal Cancer AJCC v8 Stage IIIA Rectal Cancer AJCC v8 Stage IIIB Rectal Cancer AJCC v8 Stage IIIC Rectal Cancer AJCC v8

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

Plain Language Summary

Simplified for easier understanding

This trial is studying whether a blood test that detects tumor DNA (ctDNA) can identify which rectal cancer patients are good candidates for avoiding surgery after completing radiation and chemotherapy, preserving the rectum and bowel function. **You may be eligible if...** - You are 18 or older - You have been diagnosed with stage II or III rectal cancer (confirmed by pathology) - Your cancer is confined to the rectum and has not spread to distant organs **You may NOT be eligible if...** - Your cancer has spread to distant sites (metastases) - You have already received treatment for your rectal cancer - You have received a blood transfusion within the last month Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

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

For the most up-to-date information, visit the official listing.

Visit

NCT05081024

Related Trials

A Clinical Study of Calderasib (MK-1084) With Targeted Therapy and Chemotherapy in People With Colorectal Cancer (MK-1084-012/KANDLELIT-012)

NCT06997497161 locations

Zanidatamab Before Surgery for the Treatment of HER2 Positive Colon and Rectal Cancer in Patients Planned for Curative Intent Treatment

NCT074054764 locations

Trial Utilizing Metronidazole to Optimize the Microbiome of Rectal Adenocarcinoma Undergoing Neoadjuvant Therapy

NCT065693681 location

Designing a Dyad-Based mHealth Intervention to Improve Adherence to Lifestyle Recommendations in Colorectal Cancer Survivors and Their Family Caregivers

NCT067460121 location

Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates

NCT072922983 locations