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AI and gut bacteria may decide who can avoid surgery for rectal cancer

NCT ID NCT07566559

Knowledge-focused Sponsor: Beijing Friendship Hospital 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026

Summary

This study is building a smart model that uses scans, gut bacteria, and blood tests to see if rectal cancer patients can safely avoid surgery after initial treatment. Researchers will follow 869 patients to find out who can use a 'watch-and-wait' approach instead of an operation. The goal is to control the cancer while preserving the rectum and avoiding unnecessary surgery.

What this could mean

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

What this could lead to
If successful, this could help many rectal cancer patients avoid surgery and keep their organs, while still controlling the cancer.
What could go wrong
This is an observational study, not a treatment trial. The model may not be accurate enough to replace standard care, and results may take years to validate.

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 869 people

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

Started

Jan 2025

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.

Who is studied

Patients with rectal cancer undergoing neoadjuvant therapy.

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: * The patient is informed and has provided written informed consent; * Rectal adenocarcinoma confirmed by colonoscopic biopsy and pathology, meeting the following criteria: 1. Clinical stage II/III locally advanced rectal cancer (LARC): cT1-4aN0-2M0; 2. The distal edge of the tumor is ≤ 10 cm from the anal verge (measured by MRI); 3. No distant metastasis; 4. Scheduled to receive neoadjuvant therapy; * Age ≥ 18 years, male or female。 Exclusion Criteria: * Presence of distant organ metastasis; * Multiple primary colorectal cancers; * History of prior malignancy (except completely cured carcinoma in situ of the cervix, basal cell carcinoma, or squamous cell carcinoma of the skin).

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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 cancer

How to take part

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

  1. The places running it

    1 site. 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

  • Beijing Friendship Hospital

    RECRUITING

    Beijing, Beijing Municipality, 100050, China

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