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 range

18 Years – 75 Years

Sex

ALL

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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