The Role of Gut Microbiome and Chronic Inflammation in Young-onset Colorectal Cancer

Study Overview
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Brief Summary
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This study aims to investigate the role of gut microbiome pattern and inflammation marker NF-ҡB in young-onset colorectal cancer

Official Title
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The Role of Gut Microbiome and Chronic Inflammation in Young-onset Colorectal Cancer: Next-generation Sequencing (NGS) as a Screening Method

Conditions
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Colorectal Cancer

Intervention / Treatment
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* Diagnostic Test: Score assessment
* Diagnostic Test: Blood sampling
* Diagnostic Test: Fecal sampling


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥ 35 years old Suspected with colorectal cancer and undergoing a colonoscopy procedure No history of colorectal cancer treatment Exclusion Criteria: Unwilling to provide fecal and blood sample Incomplete colonoscopy procedure due to any reasons

Ages Eligible for Study
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Minimum Age: 35 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Colorectal cancer suspects<br>Patients suspected with colorectal cancer who come to our hospital to conduct colonoscopy procedure will be recruited for this study and will undergo a series of examinations. | Diagnostic Test: Score assessment<br>* Asia Pacific Colorectal Screening (APCS) is a validated tool to predict the risk of colorectal cancer in asymptomatic Asian population. The scoring system comprises of three categories: low risk (score 0-1), moderate risk (score 2-3) and high risk (score 4-7). Patients with moderate and high risk will undergo further examinations.<br>Diagnostic Test: Blood sampling<br>* Blood samples will be taken before colonoscopy procedure to evaluate the level of serum CEA by ELISA method and to evaluate the presence of NF-ҡB by immunohistochemical method. Carcinoembryonic antigen (CEA) is a well-known marker for colorectal cancer. A pre-treatment serum CEA level of ≥ 5 ng/mL is associated with poor prognosis in colorectal cancer patients. NF-ҡB is a chronic inflammation marker found in colorectal cancer patients.<br>Diagnostic Test: Fecal sampling<br>* Fecal samples will be taken before colonoscopy procedure to be tested for FIT and to evaluate the gut microbiome. Fecal immunochemical test (FIT) is a recommended screening method for colorectal cancer. Detection of hemoglobin over a certain level in fecal samples indicated a positive FIT. Patients with positive FIT will undergo further examinations. Gut microbiome examination will be conducted with next generation sequencing (NGS) method.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gut microbiome | Gut microbiome examination will be conducted with next generation sequencing (NGS) method | pre-colonoscopy, approximately 1 day before colonoscopy | 
| Asia Pacific Colorectal Screening (APCS) score | Asia Pacific Colorectal Screening (APCS) is a validated tool to predict the risk of colorectal cancer in asymptomatic Asian population. The scoring system comprises of three categories: low risk (score 0-1), moderate risk (score 2-3) and high risk (score 4-7). Patients with moderate and high risk will undergo further examinations | pre-colonoscopy, approximately 1 day before colonoscopy | 
| Carcinoembryonic antigen (CEA) serum level | Carcinoembryonic antigen (CEA) is a well-known marker for colorectal cancer. A pre-treatment serum CEA level of ≥ 5 ng/mL is associated with poor prognosis in colorectal cancer patients. | pre-colonoscopy, approximately 1 day before colonoscopy | 
| Presence of NF-ҡB | NF-ҡB is a chronic inflammation marker found in colorectal cancer patients. Presence of NF-ҡB is assessed with immunohistochemical method. The result is considered positive if accumulated score ≥ 3. | pre-colonoscopy, approximately 1 day before colonoscopy | 
| Fecal immunochemical test (FIT) | Fecal immunochemical test (FIT) is a recommended screening method for colorectal cancer. Detection of hemoglobin over a certain level in fecal samples indicated a positive FIT. Patients with positive FIT will undergo further examinations | pre-colonoscopy, approximately 1 day before colonoscopy | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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chronic inflammation, young-onset colorectal cancer, gut microbiome, NGS