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NCT06331988Recruiting

Microbiome, Immune-system and Tumor Interaction in Colorectal Cancer

Microbiome,Immune-system and Tumor Interaction in Colorectal Cancer (MITICO Study)
European Institute of OncologyClinicalTrials.gov
Study focus
Disease/Condition
Colorectal Cancer
Study type
Observational
Sponsor & location
Primary sponsor
European Institute of Oncology
Location
Milan, Italy
Timeline & enrollment
Phase
N/A
Start date
Jul 21, 2022
End date
Jul 31, 2029
Enrollment
320 participants
Primary outcome

Relapse free survival

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.

ICD-10 classifications
Malignant neoplasm of colonMalignant neoplasm: Descending colonMalignant neoplasm: Colon, unspecifiedMalignant neoplasm: Ascending colonMalignant neoplasm: Overlapping lesion of colon
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT06331988
Type
Non-Device Trial
About this record

Access comprehensive clinical trial information for NCT06331988 through Pure Global AI's free database. This phase not specified trial is sponsored by European Institute of Oncology and is currently Recruiting. The study focuses on Colorectal Cancer. Target enrollment is 320 participants.

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