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NCT Number: NCT07494201

MIMICC Study in Patients With Colorectal Cancer

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

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Key information

Conditions

Colorectal Cancer Anastomotic Leak Colon Cancer Colonic Diseases Colonic Neoplasms Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Disease Attributes Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Rectal Cancers Rectal Diseases Rectal Neoplasms Recurrence

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Unit of Surgical Oncology - Fondazione del Piemonte per l'Oncologia- IRCCS Istituto di Candiolo, Candiolo, Turin 10060

Candiolo, Torino (TO), 10060, Italy

Location status: Recruiting

Location contact

Manuela Robella, MD

CONTACT

[email protected]

0119933630 ext. +39

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

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.

Primary outcomes

  1. 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

  2. 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

  3. 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.

  4. 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.

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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.

  5. 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

  6. 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.

  7. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Felice Borghi, MD

CONTACT

[email protected]

0119933580 ext. +39

Sponsors and collaborators

Lead sponsor

Fondazione del Piemonte per l'Oncologia

Other

Registry information

Official study title

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

Acronym: MIMICC

Important dates

Study start
2025
Primary completion
2027
Study completion
2028
First posted
Mar 27, 2026
Registry last updated
Mar 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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