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Mouth bacteria may predict colon cancer drug resistance

NCT ID NCT07619859

Knowledge-focused Sponsor: Barretos Cancer Hospital Source: ClinicalTrials.gov ↗

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
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study examines if the amount of a bacteria called Fusobacterium nucleatum in colon cancer tumors is linked to how well patients respond to targeted therapies like cetuximab or panitumumab. Researchers will analyze stored tumor samples from 500 patients with metastatic colorectal cancer. The goal is to understand why some patients do not benefit from these drugs, which could lead to better treatment choices in the future.

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 patients with metastatic colorectal cancer will benefit from anti-EGFR therapies, leading to more personalized treatment.
What could go wrong
This is an observational study, not a treatment trial. It looks at past data, so it can show links but not prove cause and effect. Results may not change practice immediately.

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 500 people

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

Started

Jul 2024

Expected to finish

Jun 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

The study population consists of patients diagnosed with metastatic (Stage IV) colorectal adenocarcinoma who received at least one cycle of anti-EGFR therapy (Cetuximab or Panitumumab) between January 2016 and December 2022 at the Hospital de Amor (Barretos, SP, Brazil). Eligible patients must have formalin-fixed paraffin-embedded (FFPE) tumor tissue samples available in the institutional biobank for molecular analysis. Patients with primary tumors outside the colon or rectum, non-adenocarcinoma histology, or with activating mutations in KRAS, NRAS, or BRAF (unless anti-EGFR was used in combination with BRAF inhibitors) are excluded.

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: * Histologically confirmed diagnosis of metastatic (Stage IV) adenocarcinoma of the colon or rectum. * Received at least one cycle of anti-EGFR therapy (cetuximab or panitumumab), either as monotherapy or in combination regimens, regardless of the line of therapy. * Anti-EGFR therapy administered between January 2016 and December 2022. * Availability of formalin-fixed paraffin-embedded (FFPE) tumor tissue blocks (from primary tumor or metastatic site) stored in the institutional biobank, with adequate quality for molecular analysis Exclusion Criteria: * Primary tumor originating in sites other than the colon or rectum. * Presence of activating mutations in KRAS or NRAS genes. * Presence of BRAF gene mutation (except for patients who received anti-EGFR therapy combined with BRAF inhibitors, according to standard clinical practice for this subgroup). * Tumor histology other than adenocarcinoma. * Insufficient clinical or follow-up data in medical records for the evaluation of the study's primary endpoints

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Conditions

The condition(s) this trial relates to.

colorectal cancer colorectal neoplasm

As listed by the trial registrant

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

Metastatic colorectal cancer (CRC)

Contacts and locations

Locations

  • Barretos Cancer Hospital

    Barretos, São Paulo, 14784-400, Brazil

More trials for these conditions

Other studies related to the condition(s) this trial covers.