Clinical trial Recruiting at 2 sites Observational Ages 18 and up

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.

More Rectal Adenocarcinoma trials

Quick facts

Study typeObservational
Ages18 Years and up
SexAll
Enrollment50 (estimated)
SponsorOHSU Knight Cancer Institute
Academic / other
Locations2 sites (Portland, Oregon and 1 other locations)
StatusRecruiting
StartedSeptember 3, 2021
Main results expectedSeptember 3, 2027
Study endsSeptember 3, 2027
Registry record updatedSeptember 16, 2026
Trial IDNCT05081024 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.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.