Exploring the role of microbiome and immune system in colorectal cancer

Microbiome,Immune-system and Tumor Interaction in Colorectal Cancer (MITICO Study)

This study is trying to understand how the gut bacteria and immune system affect colorectal cancer to help doctors make better treatment choices for patients.

Quick facts

• Study type: Observational
• Enrollment: 320 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: European Institute of Oncology (other)
• Drugs / interventions: chemotherapy
• Locations: 1 site (Milan)
• Trial ID: NCT06331988 on ClinicalTrials.gov

What this trial studies

This observational study investigates the interactions between the microbiome, immune system, and tumor characteristics in patients with colorectal cancer. It aims to identify biomolecular risk factors that could influence treatment decisions and improve patient outcomes. By analyzing data from patients undergoing curative surgery and potential adjuvant chemotherapy, the study seeks to enhance understanding of recurrence risks and treatment efficacy. The findings could lead to more personalized therapeutic approaches for colorectal cancer patients.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-75 with histologically confirmed adenocarcinoma of the colon or superior rectal cancer suitable for curative surgery.

Not a fit: Patients with metastatic colon cancer at diagnosis or those with serious underlying medical conditions may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved treatment strategies and better survival rates for colorectal cancer patients.

How similar studies have performed: Other studies have shown promise in understanding the role of microbiome and immune interactions in cancer, suggesting potential for success in this approach.

Eligibility criteria

Inclusion Criteria:

* 18 - 75 years of age
* Histologically proven adenocarcinoma of the colon and superior rectal cancer suitable for primary curative surgery at European Oncology Institute and followed by adjuvant chemotherapy if indicated.
* ECOG (Eastern Cooperative Oncology Group) Performance Status 0-1
* Written informed consent
* Patients must be willing and able to comply with scheduled visits, treatment schedule, laboratory tests and all protocol procedures.

Exclusion Criteria:

* Evidence of metastatic colon cancer at diagnosis
* Previous or concurrent malignancies, except for adequately treated basal or squamous cell skin cancer, in situ cervical cancer, or other cancer for which the patient has been disease-free for five years prior to study entry
* Psychiatric disorder precluding understanding of information on trial-related topics or giving informed consent or interfering with compliance for treatment schedule
* Any serious underlying medical conditions or serious co-morbidities which could impair the prognosis and/or the ability of the patient to participate in this trial
* Patients with active autoimmune diseases such as Inflammatory Bowel Disease, Lupus, etc. or other conditions requiring systemic corticosteroids or other systemic immunosuppressive medications.
* Use of antibiotics within 45 days from the enrollment.
* Pregnant or lactating females.
* Unwillingness or inability to follow the procedures required in the protocol.

Where this trial is running

Milan

• European Institute of Oncology — Milan, Italy (RECRUITING)

Study contacts

• Principal investigator: Davide Ciardiello, MD — Istituto Europeo di Oncologia
• Study coordinator: Davide Ciardiello, MD

Conditions: Colorectal Cancer, microbioma, Immune-system, risk factor, micro-environmental factors