Actively Recruiting

Age: 18Years - 75Years
All Genders
NCT06331988

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

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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

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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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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