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

Overview

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

Full Title of Study: “The Role of Gut Microbiome and Chronic Inflammation in Young-onset Colorectal Cancer: Next-generation Sequencing (NGS) as a Screening Method”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Cross-Sectional
  • Study Primary Completion Date: May 2022

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. 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. 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. 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. Gut microbiome examination will be conducted with next generation sequencing (NGS) method.

Arms, Groups and Cohorts

  • Colorectal cancer suspects
    • Patients suspected with colorectal cancer who come to our hospital to conduct colonoscopy procedure will be recruited for this study and will undergo a series of examinations.

Clinical Trial Outcome Measures

Primary Measures

  • 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.
  • 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.
  • 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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 35 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Fakultas Kedokteran Universitas Indonesia
  • Provider of Information About this Clinical Study
    • Principal Investigator: Murdani Abdullah, Professor – Fakultas Kedokteran Universitas Indonesia
  • Overall Official(s)
    • Murdani Abdullah, Principal Investigator, Fakultas Kedokteran Universitas Indonesia
  • Overall Contact(s)
    • Murdani Abdullah, +628129550812, kolitgastro@gmail.com

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