Microbiome, Immune-system and Tumor Interaction in Colorectal Cancer
Recruiting · NCT06331988 · Observational (researchers observe without assigning treatment) · Lead sponsor: European Institute of Oncology
View the official record on ClinicalTrials.gov →What this trial is about
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.
Who can take part
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 is running
1 location listed.
- European Institute of Oncology - Milan, Italy