RecruitingNot Applicable

MIMICC Study in Patients With Colorectal Cancer

Italy2,500 participantsStarted 2025-09-15

Plain-language 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

Who can participate

Age range18 Years – 75 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Diagnostic accuracy of fecal microbiome and fecal microRNA molecular signatures

Timeframe: 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

Timeframe: From baseline sample collection through follow-up, up to 2 years

Longitudinal change in stool and saliva microbiome and microRNA profiles

Timeframe: From diagnosis/baseline through recurrence or up to 2 years after enrollment

Integrated colorectal cancer microbiome/microRNA atlas dataset

Timeframe: From enrollment through study completion, up to 4 years

Trial details

NCT IDNCT07494201

SponsorFondazione del Piemonte per l'Oncologia

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-06-30

Contact for this trial

Felice Borghi, MD

0119933580 felice.borghi@ircc.it

View on ClinicalTrials.gov More Colorectal Cancer trials