MIMICC Study in Patients With Colorectal Cancer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorFondazione del Piemonte per l'Oncologia
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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
Prospective Biological Sample Collection and Longitudinal Molecular Profiling
Other interventionProtocol-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
Diet and Lifestyle Assessment
Other interventionAdministration 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.
Treatment groups
2,500 Participants
are divided into 1 treatment groupGroup A: Prospective Biomarker Collection CohortExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Diagnostic 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 colonoscopy2
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 years3
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 enrollment4
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 yearsSecondary outcomes
1
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 months2
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 years3
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 collection4
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/baselineSponsors and contacts
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Source ClinicalTrials.gov