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

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

Study Overview

• Status: Unknown
• Conditions: Colorectal Cancer
• Intervention / Treatment: Diagnostic test: Score assessment; Diagnostic test: Blood sampling; Diagnostic test: Fecal sampling

• Study Type: Observational
• Enrollment (Anticipated): 150

Contacts and Locations

• Study Contact: Name: Murdani Abdullah; Phone Number: +628129550812; Email: kolitgastro@gmail.com

Study Locations

• Indonesia
  • DKI Jakarta
    • Jakarta, DKI Jakarta, Indonesia, 10430
      • RSUPN dr. Cipto Mangunkusumo (Cipto Mangunkusumo Hospital)
      • Contact: Murdani Abdullah

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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. Since this is a pilot study to obtain gut microbiome pattern on colorectal cancer patients, the number of samples is determined by the researchers: 100 subjects for neoplasm and 50 subjects for non-neoplasm (according to histopathology report)

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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.

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Gut microbiome	Gut microbiome examination will be conducted with next generation sequencing (NGS) method	pre-colonoscopy, approximately 1 day before colonoscopy
Asia Pacific Colorectal Screening (APCS) score	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	pre-colonoscopy, approximately 1 day before colonoscopy
Carcinoembryonic antigen (CEA) serum level	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.	pre-colonoscopy, approximately 1 day before colonoscopy
Presence of NF-ҡB	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.	pre-colonoscopy, approximately 1 day before colonoscopy
Fecal immunochemical test (FIT)	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	pre-colonoscopy, approximately 1 day before colonoscopy

Collaborators and Investigators

• Sponsor: Fakultas Kedokteran Universitas Indonesia
• Investigators: Principal Investigator: Murdani Abdullah, Fakultas Kedokteran Universitas Indonesia

Study record dates

Study Major Dates

• Study Start (Anticipated): July 1, 2019
• Primary Completion (Anticipated): May 1, 2022
• Study Completion (Anticipated): May 1, 2022

Study Registration Dates

• First Submitted: July 2, 2019
• First Submitted That Met QC Criteria: July 4, 2019
• First Posted (Actual): July 9, 2019

Study Record Updates

• Last Update Posted (Actual): July 11, 2019
• Last Update Submitted That Met QC Criteria: July 9, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Keywords: gut microbiome; chronic inflammation; NGS; young-onset colorectal cancer
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Inflammation; Colorectal Neoplasms
• Other Study ID Numbers: 19-05-0528

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No