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Bacteria in the mouth and gut may predict who responds to cancer immunotherapy

NCT ID NCT07676461

What the study statuses mean

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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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 30, 2026 · Last updated Jul 08, 2026 · Updated 3 times

Summary

This study looks at the bacteria living in the mouth, stool, and tumors of Colombian adults with advanced cancers of the stomach, colon, breast, cervix, or head and neck who are starting immunotherapy as standard care. Researchers will compare these microbial profiles to those of healthy volunteers to see if certain bacteria are linked to better treatment response or survival. The goal is to build a Latin American Cancer Microbiome Atlas that could one day help personalize cancer care.

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 reveal bacterial patterns that help predict which patients will benefit from immunotherapy, potentially guiding future treatment decisions.
What could go wrong
This is an observational study, not a treatment trial. It may not find clear microbial signatures, and results may not apply to other populations.

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 150 people

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

Started

Jun 2026

Expected to finish

Aug 2029

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

Colombian adults with advanced solid tumors (gastric, colorectal, breast, cervical, head-and-neck) candidates for first-line immunotherapy, plus healthy adult volunteers. Single center: Fundación CTIC, Bogotá.

Ages

18 years and older

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 18 years or older. * Histologically confirmed advanced (stage III unresectable or IV) gastric, colorectal, breast, cervical or head-and-neck cancer. * Candidate for first-line immunotherapy per current clinical guidelines. * Available FFPE tumor block in institutional or reference pathology archive. * Able to provide saliva and stool samples at V0 and follow-up. * ECOG performance status within protocol limits; life expectancy over 3 months. * Cognitive capacity to give informed consent; signed EVA-BIOBANCO and Atlas consents. Inclusion Criteria (healthy controls) * No prior cancer diagnosis. * No active autoimmune disease; no inflammatory bowel disease. * No antibiotics, invasive dental treatment, immunosuppressants or corticosteroids in the prior 3 months; no severe active periodontal disease. Exclusion Criteria: * Systemic antibiotics within 3 months (except short course under 5 days for uncomplicated infection). * Probiotics or prebiotics within 30 days. * Chronic proton-pump inhibitors for more than 3 continuous months. * Inflammatory bowel disease (Crohn, ulcerative colitis) or extensive bowel resection. * Pregnancy or lactation. * BMI under 18.5 or over 40 kg/m². * Uncontrolled diabetes (HbA1c at or above 9% in prior 3 months). * Invasive dental treatment within 3 months. * Patients: simultaneous randomized trial of a non-INVIMA-approved experimental immunotherapy; or no evaluable FFPE block meeting quality thresholds. * Inability to ensure 12-month clinical follow-up.

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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

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  1. The places running it

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  2. The official record

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Contacts and locations

Locations

  • Fundación CTIC - Centro de Tratamiento e Investigación sobre Cáncer Luis Carlos Sarmiento Angulo

    RECRUITING

    Bogotá, Bogota D.C., 110131, Colombia

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