Observational Cross-reactivity Study for Colorectal Cancer Diagnosis

Observational Cross-reactivity Study to Evaluate the Specificity of a Blood Test for Colorectal Cancer Diagnosis Based on Molecular Markers and Risk Factors Identified With Artificial Intelligence Tools

The objective of this observational study is to evaluate the false positive rate of the blood test based on molecular biomarkers and risk factors. A total of 250 patients diagnosed with various cancers and gastrointestinal diseases will be enrolled. The main question to be answered is

Does the blood test have a low false positive rate in the main study population?

Participants will donate a blood sample as part of their regular medical care for cancer diagnosis and give the consent to know their clinical risk factors.

Inclusion Criteria:

• Patients older than 18 years of age at the time of blood sample collection.
• Subjects must be able to understand the information provided on the participant information sheet, must consent to participate in the study, and must sign the informed consent form.
• Patients diagnosed with only one type of cancer (no colorectal cacner) or gastrointestinal disease.

Exclusion Criteria:

• Patients who have received previous chemotherapy or radiotherapy.
• In case of diagnosis of a tumor: patients who have undergone total or partial surgical resection of the tumor.
• Patients with a personal history of advanced or non-advanced colorectal adenoma, serrated lesions, colorectal cancer, familial adenomatous polyposis or Lynch syndrome.
• Patients without appropriate staging or diagnosis.
• Patients with hemolyzed plasma.