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Blood test and AI team up to outsmart colon cancer recurrence

NCT ID NCT07673393

Knowledge-focused Sponsor: Universitaire Ziekenhuizen KU Leuven 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 29, 2026 · Last updated Jun 30, 2026 · Updated 1 time

Summary

This study explores whether combining artificial intelligence analysis of tumor tissue with special blood tests (liquid biopsy) can more accurately predict if colon cancer will return after surgery. Researchers will follow 400 adults with stage II or III colon cancer for up to five years, comparing the new methods to standard hospital assessments. The goal is to see if these tools can help doctors decide who truly needs chemotherapy and who does not.

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 approach could help doctors more accurately identify which patients need chemotherapy after colon cancer surgery and which can safely avoid it.
What could go wrong
This is an observational study, not a treatment trial. The new tests may not prove more accurate than current methods, and results may take years to confirm.

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 400 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

Sep 2033

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 MARBLE study focuses on a target population of approximately 400 adult participants with pathologically confirmed Stage II or III colon cancer. To achieve this enrollment, the study plans to screen up to 500 patients who are receiving standard-of-care surgical treatment for suspected localized colon cancer.

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: 1. Voluntary written informed consent of the participant or their legally authorized representative has been obtained prior to any screening procedures. 2. Male and female participants, at least 18 years of age at the time of signing the Informed Consent Form (ICF). 3. Newly diagnosed primary colon tumor clinically and/or histologically consistent with localized colon adenocarcinoma and planned for curative-intent surgical resection. 4. Clinical stage compatible with non-metastatic disease at time of screening and considered eligible for standard curative-intent management according to investigator assessment. 5. WHO (ECOG) performance status ≤ 3 at baseline. Exclusion Criteria: 1. Participant has been diagnosed with metastatic disease (Stage IV) 2. Participant has been diagnosed with rectal cancer 3. Participant has been diagnosed with synchronous primary colon tumors (i.e., presence of two or more primary colon tumors detected simultaneously at diagnosis) 4. Participant has received prior systemic therapy (chemotherapy, targeted therapy, immunotherapy, or radiotherapy) for colon cancer 5. Participation in an interventional Study with an investigational medicinal product (IMP) or device within 30 days prior to inclusion. 6. Participant had prior history of colon cancer requiring systemic treatment or major colorectal oncologic surgery. 7. Any severe, uncontrolled, or life-threatening medical condition that, in the opinion of the investigator, could interfere with study participation, interpretation of study assessments, or pose excessive risk to the participant (e.g. severe cardiac, hepatic, renal, or uncontrolled infectious disease).

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Conditions

The condition(s) this trial relates to.

colon adenocarcinoma colon carcinoma colonic neoplasm

As listed by the trial registrant

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

Colon adenocarcinoma Colon cancer

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.

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