Colorectal CancerMIMICCNCT07494201
MIMICC Study in Patients With Colorectal Cancer
A study testing Prospective Biological Sample Collection and Longitudinal Molecular Profiling and Diet and Lifestyle Assessment in people with Colorectal Cancer and Colon Cancer, run by Fondazione del Piemonte per l'Oncologia at 1 site in Italy.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Colorectal Cancer, Colon Cancer, Rectal Cancers
- What is being tested?
- Prospective Biological Sample Collection and Longitudinal Molecular Profiling and Diet and Lifestyle Assessment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,500 participants
- Where
- 1 siteItaly
- Study dates
- 15 Sep 2025to 30 Jun 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Unit of Surgical Oncology - Fondazione del Piemonte per l'Oncologia- IRCCS Istituto di Candiolo, Candiolo, Turin 10060
Candiolo, Torino (TO), 10060
Manuela Robella, MD, 0119933630 ext. +39, manuela.robella@ircc.it
About this study
Official title: 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
Read the 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.
- Conditions
- Colorectal Cancer, Colon Cancer, Rectal Cancers
- Being tested
- Prospective Biological Sample Collection and Longitudinal Molecular Profiling, Diet and Lifestyle Assessment
- Keywords
- microRNA, microbiome, stool biomarkers, saliva biomarkers, colorectal cancer, anastomotic leak, diet, recurrence
- Medical subject headings
- Colorectal Neoplasms, Colonic Neoplasms, Rectal Neoplasms, Anastomotic Leak, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prospective Biological Sample Collection and Longitudinal Molecular ProfilingOther
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
Diet and Lifestyle AssessmentOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: Prospective Biological Sample Collection and Longitudinal Molecular Profiling; Other: Diet and Lifestyle Assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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.
Measured: 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.
Measured: From enrollment through study completion, up to 4 years
Secondary outcomes (7)
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
Measured: From baseline to end of neoadjuvant treatment, up to 6 months
Biomarker profiles in participants with microsatellite instability-high tumors
Identification of microbiome and microRNA biomarkers associated with treatment response in participants with MSI-High colorectal cancer
Measured: 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
Measured: 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.
Measured: At diagnosis/baseline
Microbiome and microRNA profiles associated with anastomotic leak
Association between molecular profiles and the occurrence of anastomotic leak after colorectal surgery
Measured: 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.
Measured: 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
Measured: From tissue collection during routine diagnostic or surgical procedures through study completion, up to 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2026
- Study start15 Sep 2025
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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
- Masking
- None (open label)
- Enrolment
- 2,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fondazione del Piemonte per l'Oncologia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07494201
- Sponsor's protocol ID
- 005-FPO25
- Acronym
- MIMICC
- Status last verified
- Mar 2026
- First submitted
- 20 Mar 2026
- Last updated
- 27 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of MicroRNA Expression and Microbiome Composition During the Diagnostic-Therapeutic Pathway of Patients With Colorectal Carcinoma
- ClinicalTrials.gov ID
- NCT07494201
- Acronym / sponsor ID
- MIMICC / 005-FPO25
- Conditions
- Colorectal Cancer, Colon Cancer, Rectal Cancers
- Keywords
- microRNA, microbiome, stool biomarkers, saliva biomarkers, colorectal cancer, anastomotic leak, diet, recurrence
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 2,500 participants (estimated)
- Lead sponsor
- Fondazione del Piemonte per l'OncologiaUniversity, hospital or other
- Study start
- 15 Sep 2025 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Jun 2028 (estimated)
- First posted
- 27 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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
| Arm | Type | Receives |
|---|---|---|
| Prospective Biomarker Collection Cohort | Experimental | Other: Prospective Biological Sample Collection and Longitudinal Molecular Profiling, Other: Diet and Lifestyle AssessmentParticipants 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 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Prospective Biological Sample Collection and Longitudinal Molecular ProfilingProtocol-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 | Prospective Biomarker Collection Cohort |
| Diet and Lifestyle AssessmentAdministration 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. | Other | Prospective Biomarker Collection Cohort |
Primary outcome
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
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
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.
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.
7 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prospective Biological Sample Collection and Longitudinal Molecular Profiling and Diet and Lifestyle Assessment in people with Colorectal Cancer and Colon Cancer, run by Fondazione del Piemonte per l'Oncologia at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Felice Borghi, MD (0119933580 ext. +39, felice.borghi@ircc.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2026.