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

Inclusion Criteria:

• CRC Group

1. Signature of the informed consent indicating that the subject accepts toparticipate in the study and to comply with the requirements and restrictionsinherent 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 thetreating 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 toparticipate in the study and to comply with the requirements and restrictionsinherent in this study.

2. Subjects aged ≥18 years

3. Otherwise healthy individuals with recognized risk factors for CRC developmentdefined by either heredity and/or obesity and/or smoking and/or excess alcoholconsumption 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 screeningin patients with risk factors and alarm symptoms such as abdominal pain, changein 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 toparticipate in the study and to comply with the requirements and restrictionsinherent in this study.

2. Subjects aged ≥18 years

3. Otherwise healthy individuals with recognized risk factors for CRC developmentdefined by either heredity and/or obesity and/or smoking and/or excess alcoholconsumption 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 screeningin patients with risk factors and alarm symptoms such as abdominal pain, changein 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 toparticipate in the study and to comply with the requirements and restrictionsinherent in this study.

2. Subjects aged ≥40 years

3. Otherwise healthy individuals without any recognized risk factors for CRCdevelopment defined by either heredity and/or obesity and/or smoking and/orexcess 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 anunstable medical condition contraindicating the performance of the plannedblood test, stool test or breath test

4. Subject has had surgery in the previous 6-8 weeks or is under medication forCRC 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