NCT06515821 Multicentre Study for Data Collection, Development, and Evaluation of Novel CRC Screening and Diagnostic Methods
| NCT ID | NCT06515821 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Firalis SA |
| Condition | Colorectal Cancer |
| Study Type | OBSERVATIONAL |
| Enrollment | 4,100 participants |
| Start Date | 2024-08-01 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 4,100 participants in total. It began in 2024-08-01 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The primary goal is to develop easy accessible diagnostic tools for high risk subjects for colon cancer in different European populations to improve early CRC detection. These CRC screening technologies would be low cost, breakthrough and of high sensitivity and specificity.
Eligibility Criteria
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
Contact & Investigator
Markus MOELHER, MD, PhD
PRINCIPAL INVESTIGATOR
University Medical Center Mainz
Frequently Asked Questions
Who can join the NCT06515821 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Colorectal Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06515821 currently recruiting?
Yes, NCT06515821 is actively recruiting participants. Contact the research team at federica.zilli@firalis.com for enrollment information.
Where is the NCT06515821 trial being conducted?
This trial is being conducted at Sofia, Bulgaria, Sofia, Bulgaria, Besançon, France, Lübeck, Germany and 4 additional locations.
Who is sponsoring the NCT06515821 clinical trial?
NCT06515821 is sponsored by Firalis SA. The principal investigator is Markus MOELHER, MD, PhD at University Medical Center Mainz. The trial plans to enroll 4,100 participants.
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