Simple blood, breath, and stool tests could revolutionize colon cancer screening
NCT ID NCT06515821
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
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About 4,100 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Aug 2024
- Expected to finish
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Dec 2026
An estimate. End dates often move.
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
Show the full entry requirements Hide 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.
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The places running it
8 sites in 6 countries. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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IBO: Institutul Oncologic Prof. Dr. Alexandru Trestioreanu București
NOT_YET_RECRUITINGBucharest, Romania
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IPO: Instituto Português de Oncologia
RECRUITINGPorto, 4200-072, Portugal
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LSMU: Lithuanian University of Health Sciences Gastroenterology Department,
RECRUITINGKaunas, 50161, Lithuania
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MKI UKSH Lübeck
RECRUITINGLübeck, 23538, Germany
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Military Medical Academy Sofia, Gastroenterology Clinic, 3 Sveti Georgi Sofiiski str., Sofia 1606, Bulgaria
RECRUITINGSofia, 1606, Bulgaria
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UFC: Université de Franche-Comté Oncology department CHU Besançon
NOT_YET_RECRUITINGBesançon, 25030, France
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UMC Mainz: University Medical Center Mainz
RECRUITINGMainz-GE, 55131, Germany
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University Specialised Hospital for Active Treatment of Oncology Departement of Gastroenterology.
NOT_YET_RECRUITINGSofia, 1797, Bulgaria
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