MIMICC Study in Patients With Colorectal Cancer

Fondazione del Piemonte per l'Oncologia

Status: Enrolling

Conditions: Rectal Cancers; Colon Cancer; Colorectal Cancer

Treatments: Other: Prospective Biological Sample Collection and Longitudinal Molecular Profiling; Other: Diet and Lifestyle Assessment

Study type: Interventional

Funder types: Other

Identifiers

NCT07494201

005-FPO25

Details and patient eligibility

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

Full description

MIMICC is a multicenter prospective interventional academic study sponsored by Fondazione del Piemonte per l'Oncologia - IRCCS Istituto di Candiolo. Approximately 2,500 patients with histologically proven colon or rectal cancer will be enrolled. Biological samples will include stool and saliva collected at protocol-defined time points during the diagnostic and therapeutic pathway; at the sponsor center, FFPE tissue and blood/plasma samples may also be collected for additional molecular analyses. The study will investigate microbiome composition and miRNA expression profiles at diagnosis, after neoadjuvant treatment when applicable, at surgery, during postoperative follow-up, during systemic treatment, and at recurrence. Clinical, dietary, and lifestyle data will be integrated with molecular data to identify and refine biomarkers for diagnosis, prognosis, treatment response, surgical complications, and recurrence risk. Initial sample collection will be performed for approximately 4 months at the sponsor center before extension to the collaborating centers.

Enrollment: 2,500 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

2,500 participants in 1 patient group

Prospective Biomarker Collection Cohort

Experimental group

Description:

Participants with histologically confirmed colon or rectal cancer will undergo protocol-defined longitudinal collection of stool and saliva samples during the diagnostic and therapeutic pathway. At the sponsor center, FFPE tissue and blood/plasma samples may also be collected. Clinical data and diet/lifestyle questionnaire data will be prospectively recorded

Treatment:

Other: Diet and Lifestyle Assessment

Other: Prospective Biological Sample Collection and Longitudinal Molecular Profiling