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Gut bacteria could predict cancer spread, new study hopes

NCT ID NCT07154173

Knowledge-focused Sponsor: Sixth Affiliated Hospital, Sun Yat-sen University Source: ClinicalTrials.gov ↗

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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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 2 times

Summary

This study looks at gut bacteria in 300 people with colorectal cancer to see if certain bacteria are linked to cancer spread. Researchers will compare stool and tissue samples from patients whose cancer has spread versus those whose cancer has not. The goal is to find bacterial patterns that could help predict or understand metastasis.

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 identify bacterial markers that predict colorectal cancer spread, leading to earlier detection and better treatment strategies.
What could go wrong
This is an observational study, not a treatment trial. It may not find clear bacterial differences, and any findings will need much more research before they can help 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.

Participants

About 300 people

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

Started

Jan 2025

Expected to finish

Dec 2026

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

This study will enroll patients aged 18-75 years with pathologically confirmed colorectal cancer treated at the Sixth Affiliated Hospital of Sun Yat-sen University. Participants will be divided into two main groups: those with peritoneal metastasis (metastasis group) and those without distant metastasis (non-metastasis group). The study population will include both male and female patients who meet all inclusion criteria and none of the exclusion criteria. All participants must have clearly defined clinical staging and be scheduled for surgical treatment, with an expected survival of at least 3 months. Patients with recent use of antibiotics, probiotics, or immunosuppressants, those with intestinal obstruction or perforation, and those with other severe comorbidities will be excluded.

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

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: * Age between 18 and 75 years * Pathologically confirmed colorectal cancer * Clearly defined clinical staging: including imaging or pathologically confirmed metastatic colorectal cancer (stage M1) and colorectal cancer without distant metastasis (stage M0) * Expected survival ≥ 3 months * Voluntary participation and signed informed consent Exclusion Criteria: * Use of probiotics, antibiotics, or immunosuppressive agents within 1 month before surgery * Preoperative complete intestinal obstruction or gastrointestinal perforation * Intraoperative gastrointestinal perforation or tumor rupture * Previous history of gastrointestinal surgery (excluding colorectal cancer surgery, appendectomy, and cholecystectomy) or concurrent severe gastrointestinal diseases such as inflammatory bowel disease * Concurrent active systemic immune or infectious diseases, including severe allergies, rheumatoid arthritis, systemic lupus erythematosus, viral hepatitis, acquired immunodeficiency syndrome, etc. * Concurrent unhealed primary malignant tumors * Severe organ dysfunction or failure * Other conditions deemed unsuitable for this study by the investigator

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Conditions

The condition(s) this trial relates to.

colonic neoplasm colorectal cancer methemoglobinemia type 4 rectal neoplasm

As listed by the trial registrant

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

Colon neoplasms Metagenome Microbiota Rectal neoplasms

How to take part

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  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

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Contacts and locations

Locations

  • The Sixth Affiliated Hospital of Sun Yat-sen University

    RECRUITING

    Guangzhou, Guangdong, 510655, China

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