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

• Conditions: Colorectal Cancer

• Registration Number: NCT04011969
• Lead Sponsor: Fakultas Kedokteran Universitas Indonesia

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2019-07
• Study Start: 2019-07
• Study First Submitted: 2019-07-02
• Study First Submitted QC: 2019-07-04
• Study First Posted: 2019-07-09
• Last Update Submitted: 2019-07-09
• Last Update Posted: 2019-07-11
• Primary Completion: 2022-05
• Study Completion: 2022-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 150

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Presence of NF-ҡB	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.
Gut microbiome	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	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	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.
Fecal immunochemical test (FIT)	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

Trial Locations

Locations (1)

RSUPN dr. Cipto Mangunkusumo (Cipto Mangunkusumo Hospital); 🇮🇩 Jakarta, DKI Jakarta, Indonesia