MIMICC Study in Patients With Colorectal Cancer

Official title

Analysis of MicroRNA Expression and Microbiome Composition During the Diagnostic-Therapeutic Pathway of Patients With Colorectal Carcinoma

Overview

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

Detailed 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.

Interventions

• Other Prospective Biological Sample Collection and Longitudinal Molecular Profiling
  Protocol-defined collection of stool and saliva samples at diagnosis/baseline, after neoadjuvant treatment when applicable, at surgery after bowel preparation, at the time of anastomotic leak when applicable, 30 days after surgery, at day 0 of chemotherapy when applicable, at the end of chemotherapy, and at recurrence. At the sponsor center, FFPE tissue and blood/plasma samples may also be collected. Molecular analyses include microbiome profiling, miRNA sequencing, and mutational profiling on F
• Other Diet and Lifestyle Assessment
  Administration of the EPIC food frequency questionnaire and the WCRF diet/lifestyle score at diagnosis and approximately 1 year later, with integration of BMI and physical activity data.

Primary outcome measures

• Diagnostic accuracy of fecal microbiome and fecal microRNA molecular signatures [Time frame: 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 [Time frame: From baseline sample collection through follow-up, up to 2 years]
• Longitudinal change in stool and saliva microbiome and microRNA profiles [Time frame: From diagnosis/baseline through recurrence or up to 2 years after enrollment]
• Integrated colorectal cancer microbiome/microRNA atlas dataset [Time frame: From enrollment through study completion, up to 4 years]

Secondary outcome measures (7)

• Molecular signatures in patients receiving neoadjuvant treatment [Time frame: From baseline to end of neoadjuvant treatment, up to 6 months]
• Biomarker profiles in participants with microsatellite instability-high tumors [Time frame: From baseline through end of standard treatment and follow-up, up to 2 years]
• Effect of bowel preparation on fecal microbiome and microRNA profiles [Time frame: From preoperative/pre-intervention baseline to intraoperative sample collection]
• Biomarker profiles associated with early-onset colorectal cancer [Time frame: At diagnosis/baseline]
• Microbiome and microRNA profiles associated with anastomotic leak [Time frame: From surgery to first documented anastomotic leak, assessed during postoperative follow-up up to 30 days after surgery]
• Association of diet, body mass index, and physical activity with microbiome and microRNA profiles [Time frame: From diagnosis to approximately 1 year after diagnosis]
• Tumor mutational profile in FFPE tissue [Time frame: From tissue collection during routine diagnostic or surgical procedures through study completion, up to 4 years]

Eligibility 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Diagnostic

Study locations

Italy · 1 center

• Unit of Surgical Oncology - Fondazione del Piemonte per l'Oncologia- IRCCS Istituto di Can — Candiolo

Identifiers

NCT: NCT07494201 · 005-FPO25

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗