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Blood test could spot colon cancer before it spreads

NCT ID NCT07450612

Diagnosis Sponsor: San Raffaele University 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 is testing a blood test (called a liquid biopsy) to see if it can find colorectal cancer, pre-cancerous growths (adenomas), and cancers linked to Lynch syndrome at an early stage. Researchers will enroll 1,200 people who have already had a colonoscopy. The goal is to see how accurate the blood test is compared to standard methods, and whether it can also detect leftover cancer after treatment.

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 1,200 people

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

Started

Jan 2024

Expected to finish

Aug 2031

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

Seven independent cohorts of individuals who belong to one of the following seven: * Lynch syndrome, without any Lynch-syndrome-associated cancer * Lynch syndrome, with one or more Lynch-syndrome-associated cancer(s) * Sporadic colorectal cancer * Sporadic advanced adenoma (at most) * Colonoscopy-negative controls * Treatment-naive blood samples * Post-treatment blood samples

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: * All individuals included in the study need to have had a colonoscopy at the time of blood sampling. * Received standard diagnostic and staging (as necessary) procedures as per local guidelines, and at least one sample was drawn before receiving any curative-intent treatment. * Received standard pathological and endoscopic diagnosis and assessment for cohort assignment Exclusion Criteria: * Lack of informed consent * Inflammatory bowel disease

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Conditions

The condition(s) this trial relates to.

adenomatous colon polyp colon adenoma colonic disorder colonic neoplasm colorectal adenoma colorectal cancer colorectal neoplasm Colorectal Neoplasms, Hereditary Nonpolyposis Lynch syndrome Lynch syndrome 1 Lynch syndrome 2 mismatch repair cancer syndrome 1

As listed by the trial registrant

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

Adenoma colon Adenoma colon polyp Colo-rectal cancer Colon adenoma Colon disease Colon neoplasm Colorectal cancer Epcam gene mutation Lyn gene mutation Lynch syndrome Lynch syndrome I Lynch syndrome I (site-specific colonic cancer) Lynch syndrome ii Mismatch repair deficiency Mismatch repair gene mutation MLH1 gene mutation MSH2 gene mutation MSH6 gene mutation PMS2 gene mutation

How to take part

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

  1. The places running it

    4 sites. 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

  • Dipartimento di Chirurgia Oncologica e Dipartimento di Oncologia Sperimentale Istituto Nazionale Tumori

    NOT_YET_RECRUITING

    Milan, MI, Italy

  • Gastronterology and Gastrointestinal Endoscopy Unit, IRCCS San Raffaele Hospital

    NOT_YET_RECRUITING

    Milan, Lombardy, 20132, Italy

  • Prof Giulia Martina Cavestro, MD PhD

    NOT_YET_RECRUITING

    Milan, Lombardy, 20132, Italy

  • San Raffaele Scientific Institute, Gastroenterology and Gastrointestinal Endoscopy Unit

    RECRUITING

    Milan, Lombardy, 20132, Italy

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