Using blood tests to improve treatment strategies for rectal cancer
Official title: Establishing a ctDNA Biomarker to Improve Organ Preserving Strategies in Patients With Rectal Cancer
Run by OHSU Knight Cancer Institute · NCT05081024 · Data updated 2026-11-12
This study is testing if measuring tumor DNA in the blood can help doctors see how well treatments are working for people with stage II-III rectal cancer.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 50 (estimated) |
| Sponsor | OHSU Knight Cancer Institute Academic / other |
| Locations | 2 sites (Portland, Oregon and 1 other locations) |
| Status | Recruiting |
| Started | September 3, 2021 |
| Main results expected | September 3, 2027 |
| Study ends | September 3, 2027 |
| Registry record updated | September 16, 2026 |
| Trial ID | NCT05081024 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 18 and older with pathologically-confirmed stage II or III primary adenocarcinoma of the rectum.
✕Probably not a fit
Patients with distant metastases or those who have received prior treatment for rectal adenocarcinoma may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study measures circulating tumor DNA (ctDNA) levels in patients with stage II-III rectal cancer before, during, and after treatment. The goal is to determine if ctDNA presence or absence can indicate how well different treatments are working. Participants will provide blood samples at various intervals, and their medical records will be reviewed to assess treatment outcomes. The study aims to correlate ctDNA levels with clinical responses and survival rates.
Why it matters
Potential benefit: If successful, this study could lead to more personalized treatment strategies for rectal cancer, potentially improving patient outcomes.
How similar studies have gone: Other studies have shown promise in using ctDNA as a biomarker for treatment response, suggesting this approach may be effective.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
-
OHSU Knight Cancer Institute
Portland, Oregon, United States Recruiting -
Fred Hutch
Seattle, Washington, United States Recruiting
Study contacts
- Principal investigator: Adel Kardosh, M.D.,Ph.D. — OHSU Knight Cancer Institute
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Short course radiation therapy combined with chemotherapy for stage II-III rectal cancer
This study is testing a new treatment plan that combines short radiation therapy with chemotherapy to see if it helps people with stage II-III rectal cancer feel better and have fewer problems after treatment.
-
Monitoring and chemotherapy before surgery for stage II-III rectal cancer
This study tests if monitoring and chemotherapy before surgery can help people with stage II-III rectal cancer keep their organs and improve their treatment choices.
-
Evaluating quality of life after surgery for rectal cancer
This study looks at how surgery for rectal cancer affects the quality of life for patients over time, comparing those who received radiation therapy to those who didn’t.
-
Neoadjuvant Botensilimab and Balstilimab for Advanced Resectable Colorectal Cancer
This phase 2 trial tests whether giving botensilimab and balstilimab before surgery can help patients with advanced, resectable colorectal cancer see better outcomes.
-
Family genetics: who shares test results with relatives
This study tests whether letting patients share genetic results with their relatives is as good as doctors sharing the results to help first-degree relatives get genetic testing for hereditary cancer risk.
-
Neoadjuvant FOLFOX with botensilimab and balstilimab for localized rectal cancer
This test tries whether giving FOLFOX chemotherapy together with the immune drugs botensilimab and balstilimab before surgery helps people with localized rectal cancer achieve a complete clinical response.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.