MIMICC Study in Patients With Colorectal Cancer

Sponsor
Fondazione del Piemonte per l'Oncologia
Study ID
NCT07494201
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

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
  • 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.

Study Details

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

Key Dates

First listed
Mar 27, 2026
Start date
Sep 15, 2025
Status verified
Mar 2026
Primary completion
Jun 30, 2027
Completion
Jun 30, 2028

Study Design

Enrollment
2,500 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC

Arms

  • 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

Primary Outcome Measure

Diagnostic accuracy of fecal microbiome and fecal microRNA molecular signatures [ Time Frame: At diagnosis/baseline, before surgery or at least 30 days after bowel preparation for colonoscopy ]

Central Contacts

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