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MIMICC Study in Patients With Colorectal Cancer

NCT07494201 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 2500

Last updated 2026-03-27

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Fondazione del Piemonte per l'Oncologia

    lead OTHER

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-09-15
Primary Completion
2027-06-30
Completion
2028-06-30

Countries

  • Italy

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07494201 on ClinicalTrials.gov