MIMICC Study in Patients With Colorectal Cancer
Recruiting · NCT07494201 · Interventional (participants receive a specific treatment) · Lead sponsor: Fondazione del Piemonte per l'Oncologia
View the official record on ClinicalTrials.gov →Interventions studied
Diet and Lifestyle AssessmentProspective Biological Sample Collection and Longitudinal Molecular Profiling
What this trial is about
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 take part
Age range
18 Years to 75 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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 is running
1 location listed.
- Unit of Surgical Oncology - Fondazione del Piemonte per l'Oncologia- IRCCS Istituto di Candiolo, Candiolo, Turin 10060 - Candiolo, Torino (TO), Italy