About this trial
This multicenter prospective interventional study will evaluate stool and saliva microRNA expression and microbiome composition in patients with histologically confirmed colon or rectal cancer during key phases of the diagnostic and therapeutic pathway. The study aims to confirm and refine molecular signatures associated with colorectal cancer, assess the diagnostic and prognostic potential of salivary biomarkers, and characterize dynamic molecular changes during treatment and follow-up
Eligibility criteria
Qualifiers
Histologically confirmed colon or rectal cancer on endoscopic biopsy
Any T stage, any N stage, M0-M1, candidate for surgical intervention
Colon tumors with indication for surgical resection with curative intent, including right hemicolectomy, left hemicolectomy, transverse colon resection, colectomy, or total proctocolectomy
Rectal tumors with indication for upfront surgery or neoadjuvant chemoradiotherapy
Disqualifiers
Tis/T1 lesions or lesions almost completely resected by endoscopic polypectomy/EMR/ESD
Use of immunosuppressive or immunomodulatory drugs within the previous 6 months
Current or previous diagnosis of other solid or hematologic malignancies
Inability or refusal to provide informed consent
Trial design
Treatments tested in this trial
- Prospective Biological Sample Collection and Longitudinal Molecular Profiling
- Diet and Lifestyle Assessment