MIMICC: stool and saliva molecular profiling in colorectal cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.