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Blood test may predict which rectal cancer patients can skip surgery

NCT ID NCT05081024

Knowledge-focused Sponsor: OHSU Knight Cancer Institute Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Sep 17, 2026 · Updated 2 times

Summary

This study looks at whether a simple blood test can help doctors decide if rectal cancer patients can avoid surgery and keep their rectum. Researchers will measure tiny bits of tumor DNA in the blood (ctDNA) before, during, and after standard treatment. The goal is to see if changes in ctDNA levels match how well the tumor responds, potentially leading to more personalized, organ-saving care. About 50 adults with stage II or III rectal cancer will participate.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 50 people

The number the study aims to enrol. It can still change while the study runs.

Started

Sep 2021

Expected to finish

Sep 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Patients with stage II-III rectal adenocarcinoma at Oregon Health \& Science University (OHSU), its affiliated community oncology (CHO) site, or collaborating research site

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

rectal cancer rectal neoplasm rectum adenocarcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

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

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    2 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Fred Hutch

    RECRUITING

    Seattle, Washington, 98109, United States

  • OHSU Knight Cancer Institute

    RECRUITING

    Portland, Oregon, 97239, United States

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