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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Prospective Biomarker Collection Cohort | Experimental | 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 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Prospective Biological Sample Collection and Longitudinal Molecular Profiling | Other | 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 FFPE tissue |
| Measure | Description | Time Frame |
|---|---|---|
| Diagnostic accuracy of fecal microbiome and fecal microRNA molecular signatures | Diagnostic performance of predefined and refined fecal microbiome and fecal microRNA signatures, assessed using measures such as sensitivity, specificity, positive predictive value, negative predictive value, and area under the receiver operating characteristic curve for clinically relevant colorectal cancer classifications | 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 | Diagnostic and prognostic performance of salivary microbiome and microRNA profiles, assessed by classification metrics and association with disease course, treatment response, and recurrence | From baseline sample collection through follow-up, up to 2 years |
| Longitudinal change in stool and saliva microbiome and microRNA profiles | Within-participant changes in stool and saliva microbiome composition and microRNA expression profiles across the protocol-defined diagnostic and therapeutic time points. | From diagnosis/baseline through recurrence or up to 2 years after enrollment |
| Integrated colorectal cancer microbiome/microRNA atlas dataset | Number of participants with analyzable integrated molecular and clinical datasets contributing to the colorectal cancer-specific microbiome/microRNA atlas. | From enrollment through study completion, up to 4 years |
| Measure | Description | Time Frame |
|---|---|---|
| Molecular signatures in patients receiving neoadjuvant treatment | Definition and characterization of stool microbiome and microRNA signatures in participants treated with neoadjuvant total neoadjuvant therapy or chemoradiotherapy | From baseline to end of neoadjuvant treatment, up to 6 months |
| Biomarker profiles in participants with microsatellite instability-high tumors |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Felice Borghi, MD | Contact | 0119933580 | +39 | felice.borghi@ircc.it |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Unit of Surgical Oncology - Fondazione del Piemonte per l'Oncologia- IRCCS Istituto di Candiolo, Candiolo, Turin 10060 | Recruiting | Candiolo | Torino (TO) | 10060 | Italy |
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| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D003110 | Colonic Neoplasms |
| D012004 | Rectal Neoplasms |
| D057868 | Anastomotic Leak |
| D012008 | Recurrence |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
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| ID | Term |
|---|---|
| D004032 | Diet |
| ID | Term |
|---|---|
| D009747 | Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
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All enrolled participants will undergo prospective longitudinal collection of biological samples and study-specific clinical, dietary, and lifestyle data at protocol-defined time points during their standard diagnostic and therapeutic pathway for colorectal cancer. The study will start with an initial sponsor-center phase and will subsequently expand to the collaborating centers
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| Diet and Lifestyle Assessment | Other | 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. |
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Identification of microbiome and microRNA biomarkers associated with treatment response in participants with MSI-High colorectal cancer |
| From baseline through end of standard treatment and follow-up, up to 2 years |
| Effect of bowel preparation on fecal microbiome and microRNA profiles | Changes in fecal microbiome and microRNA markers after different bowel preparation strategies, with or without associated antibiotic therapy | From preoperative/pre-intervention baseline to intraoperative sample collection |
| Biomarker profiles associated with early-onset colorectal cancer | Identification of stool microbiome and microRNA signatures associated with early-onset colorectal cancer. | At diagnosis/baseline |
| Microbiome and microRNA profiles associated with anastomotic leak | Association between molecular profiles and the occurrence of anastomotic leak after colorectal surgery | 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 | Association between diet/lifestyle variables and stool/saliva microbiome and microRNA profiles. | From diagnosis to approximately 1 year after diagnosis |
| Tumor mutational profile in FFPE tissue | Mutational profiling of FFPE colorectal cancer tissue to integrate genomic data with microbiome and microRNA findings | From tissue collection during routine diagnostic or surgical procedures through study completion, up to 4 years |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D020969 | Disease Attributes |