Microbiome, Immune-system and Tumor Interaction in Colorectal Cancer

NCT06331988 | Recruiting

• 1 other identifier: IEO 1341
• Study Type: observational
• Target: 320
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Colorectal Cancer

Keywords

microbioma; Immune-system; Colorectal Cancer; risk factor; micro-environmental factors

Outcome Measures

Primary Outcomes (1)

• Relapse free survival

  To define the association between mucosal microbiota and 3y DFS in CRC patients underwent surgical resection +/- adjuvant chemotherapy

  5 years

Secondary Outcomes (1)

• Overall survival

  5 years

Study Arms (1)

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)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with resectable CRC candidate to radical surgery and - after approximately 4-8 weeks - adjuvant chemotherapy (if indicated), accordingly to standard of care (SOC).

You may qualify if:

• 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.

You may not qualify if:

• Evidence of metastatic colon cancer at diagnosis
• Previous or concurrent malignancies, except for adequately treated basal or squamous cell skin cancer, in situ cervical cancer, or other cancer for which the patient has been disease-free for five years prior to study entry
• Psychiatric disorder precluding understanding of information on trial-related topics or giving informed consent or interfering with compliance for treatment schedule
• Any serious underlying medical conditions or serious co-morbidities which could impair the prognosis and/or the ability of the patient to participate in this trial
• Patients with active autoimmune diseases such as Inflammatory Bowel Disease, Lupus, etc. or other conditions requiring systemic corticosteroids or other systemic immunosuppressive medications.
• Use of antibiotics within 45 days from the enrollment.
• Pregnant or lactating females.
• Unwillingness or inability to follow the procedures required in the protocol.

Sponsors & Collaborators

• European Institute of Oncology: lead

Study Sites (1)

European Institute of Oncology

Milan, 20141, Italy

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

blood, oral swab, faecal and tissue samples

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Davide Ciardiello, MD

  Istituto Europeo di Oncologia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Davide Ciardiello, MD

CONTACT

+390257489258; divisione.gastrointestinale@ieo.it

Cristina Mazzon

CONTACT

cristina.mazzon@ieo.it

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 18, 2024
• First Posted: March 26, 2024
• Study Start: July 21, 2022
• Primary Completion: July 31, 2026
• Study Completion (Estimated): July 31, 2029
• Last Updated: March 27, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)