The Role of Gut Microbiome and Chronic Inflammation in Young-onset Colorectal Cancer: Next-generation Sequencing (NGS) as a Screening Method
Trial Snapshot
- Phase
- Not Applicable
- Enrollment
- 150
- Locations
- 1
- Primary Endpoint
- Presence of NF-ҡB
Study Overview
Brief Summary
This study aims to investigate the role of gut microbiome pattern and inflammation marker NF-ҡB in young-onset colorectal cancer
Study Design
- Study Type
- Observational
- Observational Model
- Case Only
- Time Perspective
- Cross Sectional
Eligibility Criteria
- Ages
- 35 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Outcomes
Primary Outcomes
Presence of NF-ҡB
Time Frame: pre-colonoscopy, approximately 1 day before colonoscopy
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.
Gut microbiome
Time Frame: pre-colonoscopy, approximately 1 day before colonoscopy
Gut microbiome examination will be conducted with next generation sequencing (NGS) method
Asia Pacific Colorectal Screening (APCS) score
Time Frame: pre-colonoscopy, approximately 1 day before colonoscopy
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
Carcinoembryonic antigen (CEA) serum level
Time Frame: pre-colonoscopy, approximately 1 day before colonoscopy
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.
Fecal immunochemical test (FIT)
Time Frame: pre-colonoscopy, approximately 1 day before colonoscopy
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
Secondary Outcomes
No secondary outcomes reported
Investigators
Murdani Abdullah
Professor
Fakultas Kedokteran Universitas Indonesia