Trials / Unknown
UnknownNCT04011969
The Role of Gut Microbiome and Chronic Inflammation in Young-onset Colorectal Cancer
The Role of Gut Microbiome and Chronic Inflammation in Young-onset Colorectal Cancer: Next-generation Sequencing (NGS) as a Screening Method
- Status
- Unknown
- Phase
- —
- Study type
- Observational
- Enrollment
- 150 (estimated)
- Sponsor
- Fakultas Kedokteran Universitas Indonesia · Academic / Other
- Sex
- All
- Age
- 35 Years
- Healthy volunteers
- Accepted
Summary
This study aims to investigate the role of gut microbiome pattern and inflammation marker NF-ҡB in young-onset colorectal cancer
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DIAGNOSTIC_TEST | Score 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_TEST | Blood 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_TEST | Fecal 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. |
Timeline
- Start date
- 2019-07-01
- Primary completion
- 2022-05-01
- Completion
- 2022-05-01
- First posted
- 2019-07-09
- Last updated
- 2019-07-11
Locations
1 site across 1 country: Indonesia
Source: ClinicalTrials.gov record NCT04011969. Inclusion in this directory is not an endorsement.