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Simple blood, breath, and stool tests could revolutionize colon cancer screening

NCT ID NCT06515821

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Sep 17, 2026 · Updated 2 times

Summary

This study is testing new, easy-to-use screening tools for colorectal cancer (CRC) in over 4,000 adults across Europe. Participants provide blood, breath, stool, and cheek swab samples, which are analyzed for biomarkers, genetic risks, and chemical patterns. The goal is to develop low-cost, accurate tests that could detect CRC earlier than current methods, potentially making screening more accessible.

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 simple, low-cost screening tests that catch colorectal cancer earlier, potentially saving lives through earlier treatment.
What could go wrong
This is an observational study, not a treatment trial. The new tests may not prove accurate enough to replace current methods like colonoscopy. Results are still years away from routine use.

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 4,100 people

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

Started

Aug 2024

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Subjects aged over 18 for all groups except the control group with no risk where in this group subjects are aged ≥ 40 years.

Ages

18 years and older

Sex

Anyone

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: * CRC Group 1. Signature of the informed consent indicating that the subject accepts to participate in the study and to comply with the requirements and restrictions inherent in this study. 2. Subjects aged ≥18 years 3. Subject is willing to undergo FOBT test, colonoscopy, and tissue biopsy 4. Subject for whom the decision to perform a colonoscopy has been made by the treating physician 5. Subject has positive CRC diagnosis according to colonoscopy result 6. Covered by a Health Insurance System 7. Subject is able to comply with all study procedures * Control Group with risks and presence of polyps 1. Signature of the informed consent indicating that the subject accepts to participate in the study and to comply with the requirements and restrictions inherent in this study. 2. Subjects aged ≥18 years 3. Otherwise healthy individuals with recognized risk factors for CRC development defined by either heredity and/or obesity and/or smoking and/or excess alcohol consumption and/or hyperlipidaemia. 4. Subject be willing to undergo FOBT test, colonoscopy, and tissue biopsy 5. Subject has negative CRC diagnosis according to colonoscopy result 6. Covered by a Health Insurance System, which will cover colonoscopy as screening in patients with risk factors and alarm symptoms such as abdominal pain, change in stool texture, change in stool frequency, blood in stool/rectal bleeding, diarrhea, constipation, abdominal bloating, weight loss, tiredness. * Control Group with risks and absence of polyps 1. Signature of the informed consent indicating that the subject accepts to participate in the study and to comply with the requirements and restrictions inherent in this study. 2. Subjects aged ≥18 years 3. Otherwise healthy individuals with recognized risk factors for CRC development defined by either heredity and/or obesity and/or smoking and/or excess alcohol consumption and/or hyperlipidaemia. 4. Subject be willing to undergo FOBT test, colonoscopy, and tissue biopsy 5. Subject has negative CRC diagnosis according to colonoscopy result 6. Covered by a Health Insurance System, which will cover colonoscopy as screening in patients with risk factors and alarm symptoms such as abdominal pain, change in stool texture, change in stool frequency, blood in stool/rectal bleeding, diarrhea, constipation, abdominal bloating, weight loss, tiredness. * Control Group with no risks 1. Signature of the informed consent indicating that the subject accepts to participate in the study and to comply with the requirements and restrictions inherent in this study. 2. Subjects aged ≥40 years 3. Otherwise healthy individuals without any recognized risk factors for CRC development defined by either heredity and/or obesity and/or smoking and/or excess alcohol consumption and/or hyperlipidemia. 4. Subject be willing to undergo FOBT test 5. Subject has negative FOBT result Exclusion Criteria: * For the CRC Group 1. Legal incapacity or limited legal capacity 2. Subject did not sign the Informed Consent form 3. Subject who, according to the investigator's assessment, presents with an unstable medical condition contraindicating the performance of the planned blood test, stool test or breath test 4. Subject has had surgery in the previous 6-8 weeks or is under medication for CRC treatment. * For the control groups 1. Legal incapacity or limited legal capacity 2. Subject did not sign the Informed Consent form 3. Previous history of any type of cancer 4. Gastrointestinal disorders or other serious acute or chronic diseases

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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

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

  1. The places running it

    8 sites in 6 countries. 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

  • IBO: Institutul Oncologic Prof. Dr. Alexandru Trestioreanu București

    NOT_YET_RECRUITING

    Bucharest, Romania

  • IPO: Instituto Português de Oncologia

    RECRUITING

    Porto, 4200-072, Portugal

  • LSMU: Lithuanian University of Health Sciences Gastroenterology Department,

    RECRUITING

    Kaunas, 50161, Lithuania

  • MKI UKSH Lübeck

    RECRUITING

    Lübeck, 23538, Germany

  • Military Medical Academy Sofia, Gastroenterology Clinic, 3 Sveti Georgi Sofiiski str., Sofia 1606, Bulgaria

    RECRUITING

    Sofia, 1606, Bulgaria

  • UFC: Université de Franche-Comté Oncology department CHU Besançon

    NOT_YET_RECRUITING

    Besançon, 25030, France

  • UMC Mainz: University Medical Center Mainz

    RECRUITING

    Mainz-GE, 55131, Germany

  • University Specialised Hospital for Active Treatment of Oncology Departement of Gastroenterology.

    NOT_YET_RECRUITING

    Sofia, 1797, Bulgaria

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