Colorectal Cancer
Conditions
Keywords
chronic inflammation, young-onset colorectal cancer, gut microbiome, NGS
Brief summary
This study aims to investigate the role of gut microbiome pattern and inflammation marker NF-ҡB in young-onset colorectal cancer
Interventions
DIAGNOSTIC_TESTScore assessment
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.
DIAGNOSTIC_TESTBlood sampling
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. 1. 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. 2. NF-ҡB is a chronic inflammation marker found in colorectal cancer patients.
DIAGNOSTIC_TESTFecal sampling
Fecal samples will be taken before colonoscopy procedure to be tested for FIT and to evaluate the gut microbiome. 1. 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. 2. Gut microbiome examination will be conducted with next generation sequencing (NGS) method.
Sponsors
Fakultas Kedokteran Universitas Indonesia
Study design
Observational model
CASE_ONLY
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
35 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. Age ≥ 35 years old 2. Suspected with colorectal cancer and undergoing a colonoscopy procedure 3. No history of colorectal cancer treatment
Exclusion criteria
1. Unwilling to provide fecal and blood sample 2. Incomplete colonoscopy procedure due to any reasons
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Gut microbiome | 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 | 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 | 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. |
| Presence of NF-ҡB | 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. |
| Fecal immunochemical test (FIT) | 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 |
Countries
Indonesia
Contacts
Primary ContactMurdani Abdullah
Outcome results
None listed