MIMICC Study in Patients With Colorectal Cancer
Analysis of MicroRNA Expression and Microbiome Composition During the Diagnostic-Therapeutic Pathway of Patients With Colorectal Carcinoma
Fondazione del Piemonte per l'Oncologia
2,500 participants
Sep 15, 2025
INTERVENTIONAL
Conditions
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
Inclusion Criteria6
- 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 Criteria5
- 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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Interventions
Protocol-defined collection of stool and saliva samples at diagnosis/baseline, after neoadjuvant treatment when applicable, at surgery after bowel preparation, at the time of anastomotic leak when applicable, 30 days after surgery, at day 0 of chemotherapy when applicable, at the end of chemotherapy, and at recurrence. At the sponsor center, FFPE tissue and blood/plasma samples may also be collected. Molecular analyses include microbiome profiling, miRNA sequencing, and mutational profiling on FFPE tissue
Administration of the EPIC food frequency questionnaire and the WCRF diet/lifestyle score at diagnosis and approximately 1 year later, with integration of BMI and physical activity data.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07494201