Colorectal CancerMITICONCT06331988
Microbiome, Immune-system and Tumor Interaction in Colorectal Cancer
An observational study of Colorectal Cancer, run by European Institute of Oncology at 1 site in Italy.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Colorectal Cancer
- How many people
- 320 participants
- Where
- 1 siteItaly
- Study dates
- 21 Jul 2022to 31 Jul 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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).
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Cristina Mazzon contact
Italy1 site, 1 recruiting
- Recruiting
European Institute of Oncology
Milan, 20141
Davide Ciardiello, MD
About this study
Official title: Microbiome,Immune-system and Tumor Interaction in Colorectal Cancer (MITICO Study)
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.
Read more
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.
Read the 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 patients.The 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 patient's clinical and lifestyle information with genomic data from both, CRC and the commensal microbiota, along with profiling of local and systemic immune responses.
- Conditions
- Colorectal Cancer
- Keywords
- microbioma, Immune-system, Colorectal Cancer, risk factor, micro-environmental factors
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relapse free survival
To define the association between mucosal microbiota and 3y DFS in CRC patients underwent surgical resection +/- adjuvant chemotherapy
Measured: 5 years
Secondary outcomes (1)
Overall survival
To define the association between faecal microbiota and 3-year disease free survival (3y DFS) and 5y Overall survival (OS). To define the association between tumor intrinsic and extrinsic features and:
- 3y DFS -5y OS
- Tumor localization (e.g. right versus left)
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2024
- Study start21 Jul 2022
- Primary completion31 Jul 2026 (estimated)
- Study completion31 Jul 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- More trials run by European Institute of OncologyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 320 participants (estimated)
Sponsor and investigators
- Lead sponsor
- European Institute of Oncology
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Davide Ciardiello, MD, Principal investigator, Istituto Europeo di Oncologia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06331988
- Sponsor's protocol ID
- IEO 1341
- Acronym
- MITICO
- Status last verified
- Mar 2024
- First submitted
- 18 Mar 2024
- Last updated
- 27 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Microbiome,Immune-system and Tumor Interaction in Colorectal Cancer (MITICO Study)
- ClinicalTrials.gov ID
- NCT06331988
- Acronym / sponsor ID
- MITICO / IEO 1341
- Conditions
- Colorectal Cancer
- Keywords
- microbioma, Immune-system, Colorectal Cancer, risk factor, micro-environmental factors
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 320 participants (estimated)
- Lead sponsor
- European Institute of OncologyUniversity, hospital or other
- Study start
- 21 Jul 2022 (actual)
- Primary completion
- 31 Jul 2026 (estimated)
- Study completion
- 31 Jul 2029 (estimated)
- First posted
- 26 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 patients.The 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 patient's clinical and lifestyle information with genomic data from both, CRC and the commensal microbiota, along with profiling of local and systemic immune responses.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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).
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Relapse free survival
Time frame: 5 years
To define the association between mucosal microbiota and 3y DFS in CRC patients underwent surgical resection +/- adjuvant chemotherapy
1 secondary outcome
Overall survival
Time frame: 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Cristina Mazzon contact
Davide Ciardiello, MD principal investigator
Istituto Europeo di Oncologia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colorectal Cancer, run by European Institute of Oncology at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Davide Ciardiello, MD (+390257489258, divisione.gastrointestinale@ieo.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Relapse free survival (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2024.