Exploring the role of microbiome and immune system in colorectal cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• European Institute of Oncology
  Milan, Italy Recruiting

Study contacts

• Principal investigator: Davide Ciardiello, MD — Istituto Europeo di Oncologia
• Study coordinator: Davide Ciardiello, MD
• Email: divisione.gastrointestinale@ieo.it
• Phone: +390257489258

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.