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Microbiome, Immune-system and Tumor Interaction in Colorectal Cancer - Trial NCT06331988

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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NCT06331988
Recruiting
Trial Details
ClinicalTrials.gov โ€ข NCT06331988
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Microbiome, Immune-system and Tumor Interaction in Colorectal Cancer
Microbiome,Immune-system and Tumor Interaction in Colorectal Cancer (MITICO Study)

Study Focus

Colorectal Cancer

Observational

Sponsor & Location

European Institute of Oncology

Milan, Italy

Timeline & Enrollment

N/A

Jul 21, 2022

Jul 31, 2029

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 colon
Malignant neoplasm: Descending colon
Malignant neoplasm: Colon, unspecified
Malignant neoplasm: Ascending colon
Malignant neoplasm: Overlapping lesion of colon

Data Source

ClinicalTrials.gov

NCT06331988

Non-Device Trial