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Gut bacteria could hold key to rectal cancer prognosis

NCT ID NCT04804956

Knowledge-focused Sponsor: University Hospital of Girona Dr. Josep Trueta 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 looks at whether the types of bacteria in the gut and surrounding tissues can help predict how rectal cancer will progress. Researchers will collect stool, tissue, and fat samples from 100 people with rectal cancer and compare them to healthy controls. The goal is to find microbial 'signatures' linked to better or worse survival, which could one day help tailor treatments.

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 doctors predict which rectal cancer patients have a worse prognosis, potentially guiding more personalized treatment decisions.
What could go wrong
This is an observational study, not a treatment trial. It is small (100 participants) and early-stage, so findings may not lead to immediate clinical changes or 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.

Participants

About 100 people

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

Started

Apr 2021

Expected to finish

Apr 2028

An estimate. End dates often move.

Lead sponsor

A research network

The lead sponsor is a research network or cooperative group.

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 diagnosed with rectal cancer

Ages

18 to 18 years

Sex

Anyone

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: * Patients with colorectal cancer that will undergo elective surgery * Patients diagnosed with non-oncological disease with an indication for elective surgery. * Age ≥ 18 years * Histology proven adenocarcinoma or adenoma with or without chemotherapy or neoadjuvant radiochemotherapy * Tumoral stage equal or grater than T1 * Attempt to R0 resection * Signed informed consent by the patient and by the researcher * Dietary Questionnaire completed Exclusion Criteria: * Colorectal tumor with different histology to adenocarcinoma or adenoma * History of colorectal cancer surgery different to the local excision * Patients with psychiatric illness, addiction or disorder with inability to understand informed consent * Inability to read or understand any of the languages of the informed consent and questionnaires (Catalan, spanish) * Another synchronous malignancy * Emergency Surgery * Any patient that medical characteristics present an individual risk raised to be included and complete the study * Severe kidney or liver disease * Systemic disease with inflammatory activity, such as rheumatoid arthritis, Crohn's disease, asthma, chronic infection (HIV,TBC). * Pregnancy and lactation * Severe disorder of eating behaviour * Clinical symptoms and sings of infection in the previous month * Antibiotic, antifungal and antiviral treatment for the last 3 months * Anti-inflammatory chronic treatment * Major psychiatric antecedents * Excessive alcohol intake or drug abuse

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Conditions

The condition(s) this trial relates to.

rectal cancer rectal neoplasm

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

  • Hospital Universitari Dr. Josep Trueta de Girona

    RECRUITING

    Girona, Girona, 17007, Spain

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