MIMICC Study in Patients With Colorectal Cancer (MIMICC)

March 20, 2026 updated by: Fondazione del Piemonte per l'Oncologia

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

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
2500

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Italy
    • Torino (TO)
      • Candiolo, Torino (TO), Italy, 10060
        • Recruiting
        • Unit of Surgical Oncology - Fondazione del Piemonte per l'Oncologia- IRCCS Istituto di Candiolo, Candiolo, Turin 10060
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Prospective Biomarker Collection Cohort
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
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 FFPE tissue
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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 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
Time Frame: From baseline sample collection through follow-up, up to 2 years
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
Time Frame: From diagnosis/baseline through recurrence or up to 2 years after enrollment
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
Time Frame: From enrollment through study completion, up to 4 years
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

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Molecular signatures in patients receiving neoadjuvant treatment
Time Frame: From baseline to end of neoadjuvant treatment, up to 6 months
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
Time Frame: From baseline through end of standard treatment and follow-up, up to 2 years
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
Time Frame: From preoperative/pre-intervention baseline to intraoperative sample collection
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
Time Frame: At diagnosis/baseline
Identification of stool microbiome and microRNA signatures associated with early-onset colorectal cancer.
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 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
Time Frame: From diagnosis to approximately 1 year after diagnosis
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
Time Frame: From tissue collection during routine diagnostic or surgical procedures through study completion, up to 4 years
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Fondazione del Piemonte per l'Oncologia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 15, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 30, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 30, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 20, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 20, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 27, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 27, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 20, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 005-FPO25

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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