MIMICC Study in Patients With Colorectal Cancer

NCT07494201 | Recruiting

• 1 other identifier: 005-FPO25
• Study Type: interventional
• Target: 2,500
• Locations: 1 country
• Sites: 1

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

Conditions

Colorectal Cancer; Colon Cancer; Rectal Cancers

Keywords

microRNA; microbiome; stool biomarkers; saliva biomarkers; colorectal cancer; anastomotic leak; diet; recurrence

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (7)

• Molecular signatures in patients receiving neoadjuvant treatment

  From baseline to end of neoadjuvant treatment, up to 6 months

• Biomarker profiles in participants with microsatellite instability-high tumors

  From baseline through end of standard treatment and follow-up, up to 2 years

• Effect of bowel preparation on fecal microbiome and microRNA profiles

  From preoperative/pre-intervention baseline to intraoperative sample collection

• Biomarker profiles associated with early-onset colorectal cancer

  At diagnosis/baseline

• Microbiome and microRNA profiles associated with anastomotic leak

  From surgery to first documented anastomotic leak, assessed during postoperative follow-up up to 30 days after surgery

Study Arms (1)

Prospective Biomarker Collection Cohort

EXPERIMENTAL

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; Other: Diet and Lifestyle Assessment

Interventions

Prospective Biological Sample Collection and Longitudinal Molecular Profiling OTHER

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

Prospective Biomarker Collection Cohort

Diet and Lifestyle Assessment OTHER

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.

Prospective Biomarker Collection Cohort

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fondazione del Piemonte per l'Oncologia: lead

Study Sites (1)

Unit of Surgical Oncology - Fondazione del Piemonte per l'Oncologia- IRCCS Istituto di Candiolo, Candiolo, Turin 10060

Candiolo, Torino (TO), 10060, Italy

RECRUITING

MeSH Terms

Conditions

Colorectal Neoplasms; Colonic Neoplasms; Rectal Neoplasms; Anastomotic Leak; Recurrence

Interventions

Diet

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Disease Attributes

Intervention Hierarchy (Ancestors)

Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Central Study Contacts

Felice Borghi, MD

CONTACT

0119933580; felice.borghi@ircc.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: All enrolled participants will undergo prospective longitudinal collection of biological samples and study-specific clinical, dietary, and lifestyle data at protocol-defined time points during their standard diagnostic and therapeutic pathway for colorectal cancer. The study will start with an initial sponsor-center phase and will subsequently expand to the collaborating centers

Study Record Dates

• First Submitted: March 20, 2026
• First Posted: March 27, 2026
• Study Start: September 15, 2025
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): June 30, 2028
• Last Updated: March 27, 2026

Record last verified: 2026-03

Locations

IT (1)