NCT06331988 Microbiome, Immune-system and Tumor Interaction in Colorectal Cancer
| NCT ID | NCT06331988 |
| Status | Recruiting |
| Phase | — |
| Sponsor | European Institute of Oncology |
| Condition | Colorectal Cancer |
| Study Type | OBSERVATIONAL |
| Enrollment | 320 participants |
| Start Date | 2022-07-21 |
| Primary Completion | 2026-07-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 320 participants in total. It began in 2022-07-21 with a primary completion date of 2026-07-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Colorectal cancers represent the second leading cause of cancer-related death in the United States Western world. In Italy they represent the second most frequent neoplasm (49,000 cases in 2019). Despite the advancement of surgical techniques and medical therapy programs systemic, it is estimated that approximately 40-50% of colorectal cancers recur after being treated for a limited loco-regional disease. Patients who develop metastases throughout their history clinic have a 5-year overall survival of just over 10%. Adjuvant systemic chemotherapy can reduce the risk of disease recurrence in patients with colorectal adenocarcinomas, however, the standard drugs used to date for this use (fluoropyrimidines and oxaliplatin) have not undergone substantial changes in the last 20 years or so. A crucial point is the need to have more precise information regarding risk factors above all biomolecular to base therapeutic choices. It has now become urgent to overcome the T-tumor N-node M- metastasis (TNM) staging, to have more modern knowledge on the factors capable of impacting significantly on the prognosis, influence the real risk of disease recurrence, Identify new prognostic categories and subcategories, therefore being able to predict the clinical benefit of treatments that can be more targeted, personalized and effective. In this panorama it has developed in recent years an ever-growing literature also regarding the role of bacterial flora intestinal (microbiota) in patients with colorectal cancer. In particular, recent discoveries have highlighted the immunoregulatory role of the microbiota in the anti-tumor response. This study aims of evaluating how the molecular characteristics of the tumor, of the infiltrating immune system cells and of the associated intestinal microbiota correlate with the development of colorectal cancer, its progression and response to treatments.
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.
Contact & Investigator
Davide Ciardiello, MD
PRINCIPAL INVESTIGATOR
Istituto Europeo di Oncologia
Frequently Asked Questions
Who can join the NCT06331988 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Colorectal Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06331988 currently recruiting?
Yes, NCT06331988 is actively recruiting participants. Contact the research team at divisione.gastrointestinale@ieo.it for enrollment information.
Where is the NCT06331988 trial being conducted?
This trial is being conducted at Milan, Italy.
Who is sponsoring the NCT06331988 clinical trial?
NCT06331988 is sponsored by European Institute of Oncology. The principal investigator is Davide Ciardiello, MD at Istituto Europeo di Oncologia. The trial plans to enroll 320 participants.
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