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

NCT04011969 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 150

Last updated 2019-07-11

No results posted yet for this study

Summary

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

Conditions

Interventions

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.

Sponsors & Collaborators

  • Fakultas Kedokteran Universitas Indonesia

    lead OTHER

Principal Investigators

  • Murdani Abdullah · Fakultas Kedokteran Universitas Indonesia

Eligibility

Min Age
35 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-07-31
Primary Completion
2022-05-31
Completion
2022-05-31

Countries

  • Indonesia

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04011969 on ClinicalTrials.gov