Ignite Creation Date:
2024-05-06 @ 8:18 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06331988
Status:
RECRUITING
Last Update Posted:
2024-03-27
First Post:
2024-03-18
Brief Title:
Microbiome Immune-system and Tumor Interaction in Colorectal Cancer
Sponsor:
European Institute of Oncology
Organization:
European Institute of Oncology
Study Overview
Official Title:
MicrobiomeImmune-system and Tumor Interaction in Colorectal Cancer MITICO Study
Status:
RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MITICO
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 49000 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
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
Detailed Description:
Colorectal cancer CRC is the second leading cause of cancer-related mortality Despite the improvement of surgical techniques 30-50 of patients with locoregional CRC who undergo potentially curative surgery ultimately relapse and die of metastatic disease On the other hand it is also well established that adjuvant systemic chemotherapy can decrease the risk of death in these patients
Currently the standard treatment of locoregional CRC is based on curative surgery alone or followed by adjuvant systemic chemotherapy based on risk factors In this regard international guidelines recommend chemotherapy for stage III and stage II colon cancer with high risk prognostic characteristics including T4 lesions poorly differentiated tumors lymphovascular or perineural invasion tumour presentation with obstruction or tumour perforation positive margins and inadequate 12 number of lymph nodes analyzed after surgery In patients treated with surgery and adjuvant systemic chemotherapy the 3-year disease-free survival 3y DFS is 72 in stage III patients and 87 in stage II patientsThe risk factors known to date do not always correctly predict the prognosis in these patients For example tumors of the same stage can largely differ in both prognosis which can lead to wrong treatment decisions This means that our knowledge about factors influencing the chance of recurrence and the prediction of benefit from systemic treatment is limited Identification of these factors along with better treatment strategies may help in reducing the recurrence rate and raising the life expectancy of CRC patients In this regard the role of commensal microbiota in CRC development and response to treatments is emerging as a critical factor The term microbiome refers to the microorganisms involved but also encompasses their theatre of activity In a mutually beneficial and dynamic equilibrium bacteria coexist on our body stimulating the basal production of tissue repair factors while immune system surveils on pathogens outgrowth The gut microbiota has been consistently shown to play a role in the development of CRC The present project will establish the foundation of methods for early detection of the microbiome-immune-induced mutator phenotypes involved in the relapse Results from this study will pave the way for future interventions to constrain the mutation rates of tumor
Through this prospective observational Microbiome Immune-system Tumor Interaction in Colorectal Oncology MITICO project a new platform will be established integrating patients clinical and lifestyle information with genomic data from both CRC and the commensal microbiota along with profiling of local and systemic immune responses
Currently the standard treatment of locoregional CRC is based on curative surgery alone or followed by adjuvant systemic chemotherapy based on risk factors In this regard international guidelines recommend chemotherapy for stage III and stage II colon cancer with high risk prognostic characteristics including T4 lesions poorly differentiated tumors lymphovascular or perineural invasion tumour presentation with obstruction or tumour perforation positive margins and inadequate 12 number of lymph nodes analyzed after surgery In patients treated with surgery and adjuvant systemic chemotherapy the 3-year disease-free survival 3y DFS is 72 in stage III patients and 87 in stage II patientsThe risk factors known to date do not always correctly predict the prognosis in these patients For example tumors of the same stage can largely differ in both prognosis which can lead to wrong treatment decisions This means that our knowledge about factors influencing the chance of recurrence and the prediction of benefit from systemic treatment is limited Identification of these factors along with better treatment strategies may help in reducing the recurrence rate and raising the life expectancy of CRC patients In this regard the role of commensal microbiota in CRC development and response to treatments is emerging as a critical factor The term microbiome refers to the microorganisms involved but also encompasses their theatre of activity In a mutually beneficial and dynamic equilibrium bacteria coexist on our body stimulating the basal production of tissue repair factors while immune system surveils on pathogens outgrowth The gut microbiota has been consistently shown to play a role in the development of CRC The present project will establish the foundation of methods for early detection of the microbiome-immune-induced mutator phenotypes involved in the relapse Results from this study will pave the way for future interventions to constrain the mutation rates of tumor
Through this prospective observational Microbiome Immune-system Tumor Interaction in Colorectal Oncology MITICO project a new platform will be established integrating patients clinical and lifestyle information with genomic data from both CRC and the commensal microbiota along with profiling of local and systemic immune responses
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None