Development and Validation of Metabolic Biomarkers for Early Diagnosis, Prognosis, and Recurrence of Colorectal Cancer：MetBio-CRC

Inclusion criteria

• **Healthy Controls:**

• Age ≥ 18 years;
• Signed informed consent and willingness to participate in the project.

**Colorectal Cancer:**

• Age ≥ 18 years;
• Performance status (ECOG) score ≤ 1;
• Histopathologically confirmed colorectal adenocarcinoma;
• No family history of hereditary cancer;
• No prior anti-tumor treatment;
• Availability of primary tumor tissue from surgery or biopsy that meets submission requirements;
• Availability of peripheral blood samples that meet submission requirements;
• Willingness and ability to sign the informed consent form to participate in the study.

Exclusion criteria

• **Healthy Controls:**

• Individuals at high risk for hereditary colorectal adenocarcinoma, including family members of the following diseases: family history of gastrointestinal tumors, familial adenomatous polyposis (FAP), hereditary nonpolyposis colorectal cancer (HNPCC/LS), and Peutz-Jeghers syndrome (P-J syndrome);
• History of chronic metabolic or inflammatory diseases that are difficult to control, such as hypertension, diabetes, chronic viral hepatitis, and inflammatory bowel disease;
• Known history of other malignancies that have progressed or required treatment within the past 5 years, except for skin basal cell carcinoma and squamous cell carcinoma that have been cured;
• History of oral or intravenous use of broad-spectrum antibiotics and probiotics within the past month;
• Regular use of immunosuppressive drugs within the past 6 months;
• Long-term use of other medications that may affect metabolism, such as hormones;
• Inability or unwillingness to cooperate with follow-up visits and related examinations;
• Inability to eat normally or requiring medications or enemas for bowel movements;
• Presence of psychiatric disorders or other severe cardiovascular diseases;
• Pregnant, breastfeeding, or planning to become pregnant within the next year;
• Currently participating in an interventional clinical study or receiving study treatment that may influence the patient's treatment decision.

**Colorectal Cancer:**

• A clear family history of hereditary colorectal cancer, such as Lynch syndrome, familial adenomatous polyposis, Peutz-Jeghers syndrome, etc.;
• Currently participating in an interventional clinical study or receiving study treatment that may influence the patient's treatment decision;
• Known history of other malignancies that have progressed or required treatment within the past 5 years, except for skin basal cell carcinoma and squamous cell carcinoma that have been cured;
• History of chronic metabolic or inflammatory diseases that are difficult to control, such as hypertension, diabetes, chronic viral hepatitis, and inflammatory bowel disease;
• Presence of poorly controlled chronic comorbidities that may affect prognosis;
• Presence of psychiatric disorders or other severe cardiovascular diseases;
• Pregnant, breastfeeding, or planning to become pregnant within the next year;
• Long-term use of medications that may affect metabolism, such as hormones, immunosuppressants, antibiotics, etc.;
• Any severe and/or uncontrolled medical conditions, as judged by the investigator, that may affect the patient's ability to participate in the study or interfere with study results.