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
MIMICC is a multicenter prospective interventional academic study sponsored by Fondazione del Piemonte per l'Oncologia - IRCCS Istituto di Candiolo. Approximately 2,500 patients with histologically proven colon or rectal cancer will be enrolled. Biological samples will include stool and saliva collected at protocol-defined time points during the diagnostic and therapeutic pathway; at the sponsor center, FFPE tissue and blood/plasma samples may also be collected for additional molecular analyses. The study will investigate microbiome composition and miRNA expression profiles at diagnosis, after neoadjuvant treatment when applicable, at surgery, during postoperative follow-up, during systemic treatment, and at recurrence. Clinical, dietary, and lifestyle data will be integrated with molecular data to identify and refine biomarkers for diagnosis, prognosis, treatment response, surgical complications, and recurrence risk. Initial sample collection will be performed for approximately 4 months at the sponsor center before extension to the collaborating centers.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
2,500
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.
Unit of Surgical Oncology - Fondazione del Piemonte per l'Oncologia- IRCCS Istituto di Candiolo, Candiolo, Turin 10060
Candiolo, Torino (TO), Italy
RECRUITINGDiagnostic accuracy of fecal microbiome and fecal microRNA molecular signatures
Diagnostic performance of predefined and refined fecal microbiome and fecal microRNA signatures, assessed using measures such as sensitivity, specificity, positive predictive value, negative predictive value, and area under the receiver operating characteristic curve for clinically relevant colorectal cancer classifications
Time frame: At diagnosis/baseline, before surgery or at least 30 days after bowel preparation for colonoscopy
Diagnostic and prognostic performance of salivary microbiome and microRNA molecular signatures
Diagnostic and prognostic performance of salivary microbiome and microRNA profiles, assessed by classification metrics and association with disease course, treatment response, and recurrence
Time frame: From baseline sample collection through follow-up, up to 2 years
Longitudinal change in stool and saliva microbiome and microRNA profiles
Within-participant changes in stool and saliva microbiome composition and microRNA expression profiles across the protocol-defined diagnostic and therapeutic time points.
Time frame: From diagnosis/baseline through recurrence or up to 2 years after enrollment
Integrated colorectal cancer microbiome/microRNA atlas dataset
Number of participants with analyzable integrated molecular and clinical datasets contributing to the colorectal cancer-specific microbiome/microRNA atlas.
Time frame: From enrollment through study completion, up to 4 years
Molecular signatures in patients receiving neoadjuvant treatment
Definition and characterization of stool microbiome and microRNA signatures in participants treated with neoadjuvant total neoadjuvant therapy or chemoradiotherapy
Time frame: From baseline to end of neoadjuvant treatment, up to 6 months
Biomarker profiles in participants with microsatellite instability-high tumors
Identification of microbiome and microRNA biomarkers associated with treatment response in participants with MSI-High colorectal cancer
Time frame: From baseline through end of standard treatment and follow-up, up to 2 years
Effect of bowel preparation on fecal microbiome and microRNA profiles
Changes in fecal microbiome and microRNA markers after different bowel preparation strategies, with or without associated antibiotic therapy
Time frame: From preoperative/pre-intervention baseline to intraoperative sample collection
Biomarker profiles associated with early-onset colorectal cancer
Identification of stool microbiome and microRNA signatures associated with early-onset colorectal cancer.
Time frame: At diagnosis/baseline
Microbiome and microRNA profiles associated with anastomotic leak
Association between molecular profiles and the occurrence of anastomotic leak after colorectal surgery
Time frame: From surgery to first documented anastomotic leak, assessed during postoperative follow-up up to 30 days after surgery
Association of diet, body mass index, and physical activity with microbiome and microRNA profiles
Association between diet/lifestyle variables and stool/saliva microbiome and microRNA profiles.
Time frame: From diagnosis to approximately 1 year after diagnosis
Tumor mutational profile in FFPE tissue
Mutational profiling of FFPE colorectal cancer tissue to integrate genomic data with microbiome and microRNA findings
Time frame: From tissue collection during routine diagnostic or surgical procedures through study completion, up to 4 years
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