Actively Recruiting
Microbiome, Immune-system and Tumor Interaction in Colorectal Cancer
Led by European Institute of Oncology · Updated on 2024-03-27
320
Participants Needed
1
Research Sites
366 weeks
Total Duration
On this page
AI-Summary
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.
CONDITIONS
Official Title
Microbiome, Immune-system and Tumor Interaction in Colorectal Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 75 years
- Histologically confirmed adenocarcinoma of the colon or upper rectal cancer suitable for primary curative surgery
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
- Written informed consent provided
- Willing and able to comply with scheduled visits, treatment, laboratory tests, and all protocol procedures
You will not qualify if you...
- Evidence of metastatic colon cancer at diagnosis
- Previous or concurrent malignancies except adequately treated basal or squamous cell skin cancer, in situ cervical cancer, or other cancers disease-free for 5 years prior
- Psychiatric disorders affecting understanding or compliance
- Serious medical conditions or co-morbidities impairing prognosis or participation
- Active autoimmune diseases requiring systemic corticosteroids or immunosuppressive medications
- Use of antibiotics within 45 days before enrollment
- Pregnancy or lactation
- Unwillingness or inability to follow protocol procedures
AI-Screening
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Trial Site Locations
Total: 1 location
1
European Institute of Oncology
Milan, Italy, 20141
Actively Recruiting
Research Team
D
Davide Ciardiello, MD
CONTACT
C
Cristina Mazzon
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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