Actively Recruiting
Multicentre Study for Data Collection, Development, and Evaluation of Novel CRC Screening and Diagnostic Methods
Led by Firalis SA · Updated on 2025-09-10
4100
Participants Needed
8
Research Sites
126 weeks
Total Duration
On this page
Sponsors
F
Firalis SA
Lead Sponsor
U
University Medical Center Mainz
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Multicentre Study for Data Collection, Development, and Evaluation of Novel CRC Screening and Diagnostic Methods
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent to participate and follow study requirements
- Aged 18 years or older (40 years or older for control group without risk factors)
- Willing to undergo fecal occult blood test (FOBT), colonoscopy, and tissue biopsy (FOBT only for control group without risk factors)
- Decision made to perform colonoscopy by treating physician (CRC group)
- Positive CRC diagnosis by colonoscopy (CRC group)
- Negative CRC diagnosis by colonoscopy with or without polyps (control groups)
- Covered by a health insurance system covering colonoscopy screening
- Able to comply with all study procedures
- Control groups with risk factors defined by heredity, obesity, smoking, excess alcohol consumption, or hyperlipidemia (except control group without risks)
You will not qualify if you...
- Legal incapacity or limited legal capacity
- Did not sign informed consent form
- Unstable medical conditions contraindicating planned tests
- Recent surgery (within 6-8 weeks) or current medication for CRC treatment (CRC group)
- Previous history of any type of cancer (control groups)
- Gastrointestinal disorders or other serious acute or chronic diseases (control groups)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 8 locations
1
Military Medical Academy Sofia, Gastroenterology Clinic, 3 Sveti Georgi Sofiiski str., Sofia 1606, Bulgaria
Sofia, Bulgaria, 1606
Actively Recruiting
2
University Specialised Hospital for Active Treatment of Oncology Departement of Gastroenterology.
Sofia, Bulgaria, 1797
Not Yet Recruiting
3
UFC: Université de Franche-Comté Oncology department CHU Besançon
Besançon, France, 25030
Not Yet Recruiting
4
MKI UKSH Lübeck
Lübeck, Germany, 23538
Actively Recruiting
5
UMC Mainz: University Medical Center Mainz
Mainz-GE, Germany, 55131
Actively Recruiting
6
LSMU: Lithuanian University of Health Sciences Gastroenterology Department,
Kaunas, Lithuania, 50161
Actively Recruiting
7
IPO: Instituto Português de Oncologia
Porto, Portugal, 4200-072
Actively Recruiting
8
IBO: Institutul Oncologic Prof. Dr. Alexandru Trestioreanu București
Bucharest, Romania
Not Yet Recruiting
Research Team
F
Federica ZILLI, PhD
CONTACT
C
Céline Meyer
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
4
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