Clinical Trials Directory

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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

TypeNameDescription
DIAGNOSTIC_TESTScore assessmentAsia 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 samplingBlood 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 samplingFecal 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.