MIMICC: stool and saliva molecular profiling in colorectal cancer
Analysis of MicroRNA Expression and Microbiome Composition During the Diagnostic-Therapeutic Pathway of Patients With Colorectal Carcinoma
This project will test whether stool and saliva microRNA and microbiome markers can help diagnose and monitor colon or rectal cancer in adults aged 18–75 who are having surgery or other treatment.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 2500 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Fondazione del Piemonte per l'Oncologia Academic / other |
| Locations | 1 site (Candiolo, Torino (TO)) |
| Trial ID | NCT07494201 on ClinicalTrials.gov |
What this trial studies
MIMICC is a multicenter prospective interventional study enrolling about 2,500 adults with histologically confirmed colon or rectal cancer. Participants will provide stool and saliva samples at defined time points across diagnosis, before and after neoadjuvant treatment when applicable, at surgery, during follow-up, and if recurrence occurs; some patients at the sponsor center may also give blood/plasma and archived tumor tissue. The study will profile microbiome composition and microRNA expression and integrate clinical, dietary, and lifestyle data to identify molecular signatures linked to diagnosis, prognosis, treatment response, surgical complications, and recurrence risk. Initial sample collection begins at the sponsor site for approximately four months before expanding to collaborating centers.
Who should consider this trial
Good fit: Adults aged 18–75 with histologically confirmed colon or rectal cancer who are candidates for surgical intervention (any T/N stage, M0–M1) and can give informed consent and follow-up at the study site are ideal candidates.
Not a fit: Patients with very early lesions fully removed by polypectomy (Tis/T1), recent use of immunosuppressive/immunomodulatory drugs, active or prior other malignancies, or inability/refusal to consent or follow-up are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, the project could yield noninvasive stool or saliva biomarkers to help detect colorectal cancer earlier, predict treatment response, and monitor for recurrence.
How similar studies have performed: Related work on colorectal cancer microbiome and circulating or salivary microRNAs has shown promising biomarker signals, but these approaches are not yet widely validated for routine clinical use.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Candiolo, Torino (TO)
- Unit of Surgical Oncology - Fondazione del Piemonte per l'Oncologia- IRCCS Istituto di Candiolo, Candiolo, Turin 10060 — Candiolo, Torino (TO), Italy (Recruiting)
Study contacts
- Study coordinator: Felice Borghi, MD
- Email: felice.borghi@ircc.it
- Phone: 0119933580
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.