MIMICC Study in Patients With Colorectal Cancer (MIMICC)

Analysis of MicroRNA Expression and Microbiome Composition During the Diagnostic-Therapeutic Pathway of Patients With Colorectal Carcinoma

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

Study Overview

• Status: Recruiting
• Conditions: Colorectal Cancer; Colon Cancer; Rectal Cancers
• Intervention / Treatment: Other: Prospective Biological Sample Collection and Longitudinal Molecular Profiling; Other: Diet and Lifestyle Assessment

Detailed Description

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
• Enrollment (Estimated): 2500
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Felice Borghi, MD; Phone Number: +39 0119933580; Email: felice.borghi@ircc.it

Study Locations

• Italy
  • Torino (TO)
    • Candiolo, Torino (TO), Italy, 10060
      • Recruiting
      • Unit of Surgical Oncology - Fondazione del Piemonte per l'Oncologia- IRCCS Istituto di Candiolo, Candiolo, Turin 10060
      • Contact: Manuela Robella, MD; Phone Number: +39 0119933630; Email: manuela.robella@ircc.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Prospective Biomarker Collection Cohort; Participants with histologically confirmed colon or rectal cancer will undergo protocol-defined longitudinal collection of stool and saliva samples during the diagnostic and therapeutic pathway. At the sponsor center, FFPE tissue and blood/plasma samples may also be collected. Clinical data and diet/lifestyle questionnaire data will be prospectively recorded

Other: Prospective Biological Sample Collection and Longitudinal Molecular Profiling; 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; Other: Diet and Lifestyle Assessment; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	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.	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.	From enrollment through study completion, up to 4 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	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	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.	At diagnosis/baseline
Microbiome and microRNA profiles associated with anastomotic leak	Association between molecular profiles and the occurrence of anastomotic leak after colorectal surgery	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.	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	From tissue collection during routine diagnostic or surgical procedures through study completion, up to 4 years

Collaborators and Investigators

• Sponsor: Fondazione del Piemonte per l'Oncologia

Study record dates

Study Major Dates

• Study Start (Actual): September 15, 2025
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): June 30, 2028

Study Registration Dates

• First Submitted: March 20, 2026
• First Submitted That Met QC Criteria: March 20, 2026
• First Posted (Actual): March 27, 2026

Study Record Updates

• Last Update Posted (Actual): March 27, 2026
• Last Update Submitted That Met QC Criteria: March 20, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: colorectal cancer; anastomotic leak; microRNA; recurrence; diet; microbiome; stool biomarkers; saliva biomarkers
• Additional Relevant MeSH Terms: Postoperative Complications; Pathologic Processes; Neoplasms by Site; Neoplasms; Disease Attributes; Intestinal Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colonic Diseases; Pathological Conditions, Signs and Symptoms; Rectal Neoplasms; Recurrence; Colorectal Neoplasms; Colonic Neoplasms; Anastomotic Leak; Diet, Food, and Nutrition; Physiological Phenomena; Nutritional Physiological Phenomena; Diet
• Other Study ID Numbers: 005-FPO25

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No