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Blood test may decide who needs surgery for rectal cancer

NCT ID NCT07209215

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Aug 06, 2026 · Updated 3 times

Summary

This phase 2 trial tests whether a highly sensitive blood test (ctDNA) can help manage treatment for 200 people with early-stage rectal cancer. After standard chemotherapy and radiation, some patients will have their treatment guided by the blood test results instead of immediate surgery. The study aims to see if this approach can achieve similar cancer control while possibly avoiding unnecessary surgery.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Signatera Genome ultra-sensitive ctDNA blood test
What this could lead to
If successful, this could show that a blood test helps doctors decide who needs surgery and who can safely avoid it after initial treatment.
What could go wrong
This is an early-phase study with only 200 participants. The blood test may not be accurate enough to guide decisions, and results may not apply to all patients.

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.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 200 people

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

Expected to start

Oct 2026

An estimate. Start dates often move.

Expected to finish

Dec 2028

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.

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: * Tumor tissue histologically confirming rectal adenocarcinoma that is available for Natera ctDNA assay. * Cohort A only: Patients appropriate for receiving TNT including chemotherapy and chemoradiation. * Cohort B only: TNT must have included at least 4 cycles of CAPEOX or 6 cycles of FOLFOX and at least 45 Gy in 25 fractions to the pelvis during chemoradiation. * Patients ≥18 years of age at time of consent. * Ability to understand and willingness to sign the informed consent form (ICF). * Ability and stated willingness to adhere to the study visit schedule and protocol procedures/requirements. Exclusion Criteria: * Prior treatment for rectal cancer, except for cohort B. * Evidence of distant metastatic disease on staging imaging (CT chest with abdominopelvic imaging by CT or MRI) within 8 weeks of enrollment. * Patients on hemodialysis. * Any condition that in the opinion of the investigator would interfere with the participant's safety or compliance while on trial

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

How to take part

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

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    1 site. The list below names each one and where it is.

  3. 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 ↗

  4. 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

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • University of California Davis Comprehensive Cancer Center

    Sacramento, California, 95817, United States

    Contact Email: •••••@•••••

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