Colorectal Cancer Clinical Trials

Find Colorectal Cancer Clinical Trials Near You

Microbiome,Immune-system and Tumor Interaction in Colorectal Cancer (MITICO Study)

Status: Recruiting
Location: See location...
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Italy
European Institute of Oncology
RECRUITING
Milan
Contact Information
Primary
Davide Ciardiello, MD
divisione.gastrointestinale@ieo.it
+390257489258
Backup
Cristina Mazzon
cristina.mazzon@ieo.it
Time Frame
Start Date: 2022-07-21
Estimated Completion Date: 2029-07-31
Participants
Target number of participants: 320
Treatments
resectable colorectal cancer patient
patients with resectable CRC candidate to radical surgery and - after approximately 4-8 weeks - adjuvant chemotherapy (if indicated), accordingly to standard of care (SOC)
Related Therapeutic Areas
Sponsors
Leads: European Institute of Oncology

This content was sourced from clinicaltrials.gov

Similar Clinical Trials