NCT07494201 MIMICC Study in Patients With Colorectal Cancer
| NCT ID | NCT07494201 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Fondazione del Piemonte per l'Oncologia |
| Condition | Colorectal Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 2,500 participants |
| Start Date | 2025-09-15 |
| Primary Completion | 2027-06-30 |
Trial Parameters
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Brief Summary
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
Inclusion Criteria: * 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 * Written informed consent signed before any study procedure * Age between 18 and 75 years Exclusion Criteria: * 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 * Inability or refusal to be followed at the study institution/network
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