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A new clue in the fight against colorectal cancer recurrence?

NCT ID NCT07744139

Knowledge-focused Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 04, 2026 · Last updated Aug 07, 2026 · Updated 3 times

Summary

This study looks at whether a combination of immune cell activity, genetic changes, and imaging features can help predict if colorectal cancer that has spread to the liver will come back after surgery. Researchers will analyze tumor tissue, blood samples, and scans from about 210 patients who had liver surgery for colorectal cancer metastases. The goal is to build a model that could one day help doctors personalize follow-up care and catch recurrence earlier.

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 lead to a predictive tool that helps doctors identify patients at higher risk of cancer recurrence after liver surgery, enabling more personalized follow-up and treatment decisions.
What could go wrong
This is an observational study, so it won't test a new treatment. The predictive model may not prove accurate enough for routine use, and findings from this single-center study may not apply to broader 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 210 people

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

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Dec 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

Adult patients with metastatic colorectal cancer and histologically confirmed colorectal liver metastases undergoing standard clinical management and curative-intent liver resection at Fondazione Policlinico Universitario A. Gemelli IRCCS. The study includes both a retrospective cohort with available tumour tissue and clinical data and a prospective cohort undergoing collection of tumour tissue and peripheral blood samples during routine clinical care

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: * Age ≥18 years. * Histologically confirmed colorectal liver metastases. * Administration of neoadjuvant chemotherapy prior to liver resection, with objective tumour response classified as partial response (PR) or stable disease (SD) according to RECIST criteria. * Availability of a hepatobiliary contrast-enhanced MRI performed within 2 months before surgery. * Provision of informed consent for prospectively enrolled participants, or eligibility under Article 110-bis of the Italian Privacy Code for retrospectively enrolled participants. Exclusion Criteria: * Recurrent metastatic disease. * Liver resection performed with non-curative intent. * Current or previous hepatitis B virus (HBV) or hepatitis C virus (HCV) infection. * Concomitant malignancies or history of another malignancy treated within the previous 5 years.

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Conditions

The condition(s) this trial relates to.

colon carcinoma colonic neoplasm colorectal cancer

As listed by the trial registrant

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

Colo-rectal cancer Colon cancer Liver metastases

How to take part

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

  1. 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 ↗

  2. 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.

More trials for these conditions

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