Multicentre Study for Data Collection, Development, and Evaluation of Novel CRC Screening and Diagnostic Methods

NCT06515821 | Recruiting DMC

• 1 other identifier: 2023-A01793-42
• Study Type: observational
• Target: 4,100
• Locations: 6 countries
• Sites: 8

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.

Conditions

Colorectal Cancer

Keywords

early CRC detection; biomarkers; diagnostic tool; high risk subject; colorectal cancer

Outcome Measures

Primary Outcomes (5)

• ONCO CTC expression pattern of ONCOSCREEN tools in CRC patients and healthy controls using colonoscopy as the reference method.

  Blood samples will be collected to assess various novel biomarkers associated with CRC.

  At the day of visit/sampling and through study completion, an average of 3 years

• ONCO NMR expression pattern

  Blood samples will be collected to assess various novel biomarkers associated with CRC.

  At Day1 and through study completion, an average of 3 years

• ONCO CRISPR expression pattern

  Blood and stool samples will be collected to assess various novel biomarkers associated with CRC.

  At Day1 and through study completion, an average of 3 years

• ONCO VOC expression pattern

  Breath samples will be collected to analyze volatile organic compounds (VOCs). By examining the electrochemical signal responses using pattern recognition algorithms, researchers can identify early indicators distinguishing between CRC-linked and healthy categories.

  At Day1 and through study completion, an average of 3 years

• Evaluation of genetic risks associated to CRC

  Buccal swabs will be collected to evaluate genetic risks associated to CRC. Analyzing buccal swab samples can identify genetic variations linked to an increased CRC risk, enhancing personalized screening accuracy.

  At Day1 and through study completion, an average of 3 years

Study Arms (4)

CRC Group

Subject has positive CRC diagnosis according to colonoscopy result

Diagnostic Test: ONCOSCREEN

Control Group with risks and presence of polyps

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.

Diagnostic Test: ONCOSCREEN

Control Group with risks and absence of polyps

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.

Diagnostic Test: ONCOSCREEN

Control Group with no risks

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.

Diagnostic Test: ONCOSCREEN

Interventions

ONCOSCREEN DIAGNOSTIC_TEST

Subjects samples will be tested with diagnostic tests.

CRC Group; Control Group with no risks; Control Group with risks and absence of polyps; Control Group with risks and presence of polyps

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• CRC Group
• 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.
• Subjects aged ≥18 years
• Subject is willing to undergo FOBT test, colonoscopy, and tissue biopsy
• Subject for whom the decision to perform a colonoscopy has been made by the treating physician
• Subject has positive CRC diagnosis according to colonoscopy result
• Covered by a Health Insurance System
• Subject is able to comply with all study procedures
• Control Group with risks and presence of polyps
• 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.
• Subjects aged ≥18 years
• 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.
• Subject be willing to undergo FOBT test, colonoscopy, and tissue biopsy
• Subject has negative CRC diagnosis according to colonoscopy result
• 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.

You may not qualify if:

• For the CRC Group
• Legal incapacity or limited legal capacity
• Subject did not sign the Informed Consent form
• 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
• Subject has had surgery in the previous 6-8 weeks or is under medication for CRC treatment.
• For the control groups
• Legal incapacity or limited legal capacity
• Subject did not sign the Informed Consent form
• Previous history of any type of cancer
• Gastrointestinal disorders or other serious acute or chronic diseases

Sponsors & Collaborators

• Firalis SA: lead
• University Medical Center Mainz: collaborator

Study Sites (8)

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

Sofia, 1606, Bulgaria

RECRUITING

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

Sofia, 1797, Bulgaria

NOT YET RECRUITING

UFC: Université de Franche-Comté Oncology department CHU Besançon

Besançon, 25030, France

NOT YET RECRUITING

MKI UKSH Lübeck

Lübeck, 23538, Germany

RECRUITING

UMC Mainz: University Medical Center Mainz

Mainz-GE, 55131, Germany

RECRUITING

LSMU: Lithuanian University of Health Sciences Gastroenterology Department,

Kaunas, 50161, Lithuania

RECRUITING

IPO: Instituto Português de Oncologia

Porto, 4200-072, Portugal

RECRUITING

IBO: Institutul Oncologic Prof. Dr. Alexandru Trestioreanu București

Bucharest, Romania

NOT YET RECRUITING

Related Links

• Website of the clinical study

Biospecimen

Retention: SAMPLES WITH DNA

Blood, Breath, Faeces, Buccal swab

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Markus MOELHER, MD, PhD

  University Medical Center Mainz

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Federica ZILLI, PhD

CONTACT

+33 (0) 389911320; federica.zilli@firalis.com

Céline Meyer

CONTACT

celine.meyer@firalis.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 28, 2024
• First Posted: July 23, 2024
• Study Start: August 1, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: September 10, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

RO (1); PT (1); BU (2); FR (1); DE (2); LI (1)