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

• Conditions: Colorectal Cancer
• Interventions: Diagnostic Test: Score assessment; Diagnostic Test: Blood sampling; Diagnostic Test: Fecal sampling

• 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

Arm && Interventions

Group	Intervention	Description
Colorectal cancer suspects	Blood sampling	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.
Colorectal cancer suspects	Fecal sampling	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.
Colorectal cancer suspects	Score assessment	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.

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